Alternatives to LICENSALE

RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.

Compliance & Risks works closely with some of the most prominent brands in the world, including Dyson, Caterpillar and Samsung. We simplify the Product Compliance process to unlock market access. Three key elements are part of our offering: 1. Enterprise technology solution to improve productivity and efficiency with C2P The market's most comprehensive regulatory content, with 40+ topics covering over 20+ industries and 195 nations worldwide. 2. A team of subject matter experts are available to answer any regulatory questions you may have 3. We help you to monitor and assess the relevant regulations and standards that apply to your products and business. We also help you prove product compliance in order for your business to remain on the market and grow. We have over 20 years experience working with some of the most iconic brands in the world and have a remarkable track record of helping companies to manage compliance risks more effectively than ever.

Essenvia delivers business value to all departments and teams, and increases efficiency across the board. Centralized repository of all regulatory information allowing collaborative authoring, reporting, and eliminating technical holds, RTAs and RFIs. The regulatory affairs department is empowered to accelerate product launches, and eliminate revenue losses due to delays in submissions and missed renewals. Helicopter view over the entire regulatory lifecycle. Executive dashboards, metrics and proactive alerts are available for global registrations and submissions. Essenvia, a RIM Platform, allows you to manage regulatory workflows throughout the entire product lifecycle. It also accelerates global market access and generates exponential business value. Consolidate all regulatory activities onto one platform to bring your devices faster to market. All registration documents linked to product master information are stored in a central repository. Manage the product registration lifecycle per country.

All the information you need to register your IVD product or medical device in any market worldwide and manage your market access licence throughout the product's life cycle. REGISLATE®, which provides information about medical and IVD device-specific submission file requirements for each country, allows users to manage their market access licenses through the product life cycle. You can track milestones, timelines, estimated and actual completion dates, as well as estimated and actual completion dates, for initial registrations, renewals, amends, and license transfers, in real-time. For clear monitoring and management, infographic data and proprietary indicators are available. Collaboration tools are available to assist with the preparation and review submissions, compliance requirements, and documents. Receive progress reports in real time for current and future submissions, including market access readiness index. REGISLATE®, which includes GR-MAP registration tracking, for both country AND product.

ClinChoice manages global regulatory data with technology expertise, a deep understanding and best data management practices. ClinChoice uses its expertise in technology and regulatory affairs to help organizations manage their regulatory information. Our consultants offer general data maintenance support in regulatory Information Management System (RIMS) software. This will help ensure that applications are submitted, approved, renewed, and tracked on time. We offer the necessary support in managing and controlling the drug registration process. This allows drug and medical device manufacturers to track all regulatory information and has the ability to see it. Organizations can develop short-term and long-term strategies that meet submission deadlines with minimal impact on their day-to-day operations.

Rimsys provides a single, cloud platform for end-to-end regulatory process digitization and automation. Designed by and for regulatory affairs professionals, Rimsys helps medtech companies reduce repetitive administrative work, speed time to market, respond faster to changing regulations, and drive alignment across internal teams, affiliates, and partners. Only Rimsys provides a holistic platform that supports a full range of regulatory activities. Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions. Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions. Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes. Get notified of changing standards, laws, regulations, and guidance documents that impact your products. Create self-service application, product, and country reports to see exactly where your products can be sold and their current registration status.

The regulatory affairs departments in the healthcare and life science industry are driven to improve efficiency and create intelligent systems that optimize costs, maximize accuracy, and reduce submission times. RIMTrack, a cloud-ready, artificial intelligence (AI)-based, new age regulatory information management system, addresses this concern. It was created from scratch to assist organizations in preparing submissions accurately and efficiently. It streamlines regulatory processes related to licensing, approvals, regulatory, competitive intelligence, clinical trials and reporting across global stakeholders. Integrate with existing RIM systems to achieve complete management of the regulatory lifecycle process.

PhlexRIM dramatically improves compliance by providing you with real-time, efficient and effective access to your global registration information. PhlexRIM 2.0 includes a library of pre-configured automation "bots" and built-in regulatory use case examples based on industry best practice. The intuitive drag-and drop design tool allows regulatory teams to automate their business processes without the need for programming knowledge or IT support. Manage the entire lifecycle of pharmaceutical product registration activities. Access detailed status information and make use of the alert management feature that is part of all workflows. You can either use standard reports to illustrate your reports or create your own reports. You can create and assign regulatory tasks to your organization for management, headquarters, and affiliates.

End-to-end regulatory information management from a single platform. The Vault RIM Suite streamlines global regulatory process on a single cloud-based platform. This allows life sciences companies to increase visibility, data quality, agility, and efficiency. You can respond faster to changes in regulations and improve process efficiency, from submission planning to publication. Coordinate regulatory efforts across HQ and affiliates within a single RIM platform. Assure that teams are creating reliable regulatory content with high data integrity. Veeva Vault Registrations manages product data worldwide, including variations, registration status, and interactions with health authorities. Veeva's flexible data structure supports IDMP data points, and will continue to support changing regulatory data standards. Veeva Vault Submissions automates regulatory process steps and streamlines submission planning.

Freya is an advanced AI regulatory assistant that simplifies the process of understanding and navigating complex regulations. By leveraging a vast database of over 40,000 global regulations, Freya provides real-time, verified answers to regulatory questions and offers tools like document translations and summaries. The platform supports compliance management by offering up-to-date regulatory information, ensuring businesses stay informed and efficient. Powered by AI and verified by industry experts, Freya enables organizations to make faster, more accurate decisions while managing their regulatory obligations across multiple markets.

Samarind RMS is a smarter way for you to manage your medical product information. Samarind RMS allows you to only enter data once, and you can reuse it as often as necessary. An example of this is the 'INN' which can be used once and reused for all IMA submissions, renewals and variations. This concept is applicable to all key data within the system. It has been proven to improve data quality and streamline workflows. Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system. An electronic document management system (EDMS), which includes version control, template creation, and the ability to link with external document management systems like Documentum™, SharePoint™.

ViSU™, a cloud-based End-to End Regulatory Information Management platform (RIM), is specifically designed for the medical device industry. It allows global users to access and manage regulatory data (Product Master and Registrations, Tracking), Dossiers/Tech files (Submission planning and building & lifecycle), HA/NB correspondence and Obligations tracking. ViSU helps you embrace digitalization in regulatory. It provides connectivity, traceability, and automation which leads to regulatory management efficiency, lower compliance risks, and cost reduction.

Kalypso offers life sciences companies a cost-effective accelerator to implement a RIM system - Accel for RIM. The integrated platform allows for efficient product distribution and management, as well as a global platform to track and manage product registrations. It consolidates compliance data and quality data from different enterprise solutions into one global source of truth to facilitate product registrations and tracking in order to speed up regulatory submissions. Modern APIs are used to combine product data, regulatory documentation, and submission packages. Pre-configured for quick implementation with a valid software system. Based on industry-leading RIM practices.

You can speed up the time to market by organizing, executing and tracking all regulatory activities within a single RIM application. This allows you seamless access to all regulatory documents and full support for all eCTD submission requirements. Automation is integrated to streamline workflows and increase confidence in product registration data quality. You can speed up the time to market by organizing, executing, tracking, and planning all regulatory activities in a single RIM application. This allows you seamless access to all regulatory documents and full support for all eCTD submission requirements. Automation is integrated to streamline workflows and increase confidence in product registration data quality.

RegDocs Connect provides the tools for your regulatory and operational teams to create compliant, submission-ready documents and records. This solution is built with the end user in view. It focuses on collaboration, automation, and quality. Automated workflows allow you to manage your records from draft to final. This allows your team to have complete control over your regulatory documents at any time. The mapping of document types to the EDM Reference Model and eCTD allows for organization and retrieval of documents that can be used in regulatory submissions. The powerful tools of PDF/A Publishing, document classification, unique document identifiers, and EDM reference model facilitate regulatory document management. This solution pulls together information from all levels of your organization into one easy-to-use solution. The ability to produce submission-ready and quality content has become more difficult due to electronic submissions to regulatory authorities and the complexity of drug development.

Imagine all your regulatory information about products, registrations and submissions, correspondence, and commitments in one central place, accessible from anywhere. Ennov RIM allows life sciences companies to streamline their regulatory processes, improve data quality, quickly respond to business-critical questions, and effectively responds to health authority requests. Ennov RIM, a purpose-built application based on Ennov Process, allows for the tracking and management of therapeutic product details as well as registration information. Ennov RIM gives regulatory personnel the essential information and functionality they need to manage product portfolios globally, whether you're planning to launch a new product or handle variations to existing registrations.

RIMExpert™, which addresses regulatory planning, tracking, and data management, manages the global rollout plans and automates the creation of regulatory activities, medicinal products, and regulatory applications. RIMExpert™, reduces data entry requirements, improves data quality, and increases global oversight and control. Standardize regulatory planning, tracking, and registration management processes. Increase collaboration between affiliates and headquarter. All registration activities can be done in one place. One point of contact for all applications, questions, correspondence, and commitments. To maximize the efficiency of enterprise regulatory resources, sync your efforts. You can monitor registration activities throughout the product's lifecycle, keeping track of deadlines, status of commitments, and agency questions. Interactive dashboards to monitor and control regulatory activities and registrations.

DXC RIM platform manages regulatory content, data and workflows in one central place. This helps teams accelerate innovation and reduces time to market. A unified platform is required to manage regulatory data and workflows due to the sensitive nature of regulatory affairs content (RA). All relevant data must be easily accessible to all teams. They also need an intuitive, customizable user interface that is simple to use. While configurable reporting and collaborative tools are essential for success, legacy technology can frustrate teams or slow down processes. Compliance is difficult. It is difficult to collect data and document processes. Life sciences organizations that use disparate technologies and have fragmented legacy systems can create problems. They may need to resort to spreadsheets in some cases to manage key operational processes. A centralized enterprise-grade solution is required to bring products to market and manage RA.

Dow Jones Risk & Compliance, a global provider, provides best-in class risk data, web based software applications, and scalable due-diligence services to help organizations manage risks and meet regulatory requirements in relation to financial crime, third party risk management, international trade, and sanctions. Dow Jones Risk & Compliance is built on the legacy of the world's trusted newsroom. It combines the expertise and knowledge of a multilingual team of researchers with the industry-leading data scientists, technologists and analysts to provide actionable compliance content. Our solutions were created in partnership with leading legal and political advisors, including former regulators, to help our clients maintain consistency among global business units and teams.

IQVIA Smart, our new end-to-end regulatory information management software, streamlines regulatory processes. Your team can focus on delivering high-quality products to the market instead of labor-intensive maintenance. RIM Smart, the modern regulatory information management system, is designed to improve speed, collaboration, efficiency, visibility, and performance across your entire global portfolio. It also reduces costs. IQVIA RIM Smart is a secure cloud-based solution that allows for interconnected, comprehensive, and intelligent management of all regulatory processes. IQVIA safety platform integration will increase performance and improve flexibility. Automate manual processes and increase connectivity to improve efficiency, cost savings and coordination as well as cross-enterprise visibility and visibility.

Secure Multi-Data Archiving with a Single Interface OneVault archives email and all new data types that your organization uses today. Email, Instant Messaging and Teams, Zoom, Webex, and many other data types. OneVault gives you a single interface to archive from multiple systems. It is easy to organize consistent policies and support business continuity plans by centralizing important data in a secure cloud platform. e-Discovery is a single platform for managing and working with records. It is secure, transparent, and easy to use. OneVault combines the powerful features of our stand alone archiving solutions under one pane of glass. It is intuitive, secure, and scalable. Start with email and expand as new systems become available.

Our enterprise document management software is the best in its class. Meridian offers a single source for truth and configurable workflows that streamline collaboration with all departments. It also ensures that every document change is versioned, audited, and reported to the regulatory authorities. Engineering document management refers to the process of finding, finding, and managing complex engineering documents, including CAD files, drawings, technical documents, and communication documents, in AEC organizations (Architecture, Engineering & Construction). Businesses in these industries can find it difficult to manage their engineering documents effectively. Meridian's document management software for engineering projects can address these concerns. Meridian can centralize documents and drawings within an organization while automating key processes.

harmon.ie allows knowledge workers to easily capture and classify email and documents to SharePoint and Teams from Outlook, where they spend most of their work time. It is easy to find and share important content right from your email client. harmon.ie makes it easy to do the right things, increasing SharePoint adoption and workplace productivity as well as information governance compliance. Thousands of enterprise customers rely on harmon.ie's SharePoint- and Office 365-based user experiences products for email, records management, collaboration, knowledge preservation, and SharePoint adoption. harmon.ie is a Microsoft Partner since 2003 and has won many Microsoft Best App Awards. Our flagship solution eliminates data silos in Office 365 apps by grouping information with Descriptive Labels. harmon.ie SmartAssistant allows organizations to bring together all their information so that employees can concentrate on work.

AmpleLogic Regulatory Tracker is built using the LOW CODE AND NEUTRAL CODE (LCNC PLATFORM) and consists of two modules: ANDA Tracker and DMF Tracker. This Pharmaceutical RIMS Software will help you improve data quality, increase operational efficiency, reduce mistakes, and streamline communications across departments.

High-cost contributors are essential for regulatory functions. They can be found in a wide range of regulatory content. This problem can be solved by a cloud-based solution like Infosys' regulated document management platform. Externalization, collaborative authoring, and editing. Simplify governance and processes; implement a consumption-based model. Support audit trails. Implement a proven solution that guarantees 99.95% uptime in production. Our solution allowed business users to search documents in a vast repository in just 3/4 seconds. Users also had unlimited storage on-demand. To reduce operational and maintenance costs, the DMS uses Google's application programming interfaces (APIs). The company's overheads are restricted to API usage and storage space.

EXTEDOpulse, a comprehensive RIM software solution, consists of five hubs that address all stages of product development. You can use the applications separately or combine them to get additional value based on your needs. The development of pharmaceutical products can be complex and require input from many people. Life science organizations face many challenges due to the complexity of operating in a highly regulated industry. We are able to provide you with great synergy and connection, as well as innovation, for compliance. EXTEDOpulse was designed with these aspects in view to help you connect the dots throughout the entire lifecycle pharmaceutical products. EXTEDO is familiar with the complexities involved in the regulatory pharmaceutical product journey.

Select the only solutions that you need right away. You can add more capabilities later on. The LORENZ Foundation manages Controlled Vocabularies and Repository Management, Interoperability Management, and User Management. This centrally streamlines system management, maintenance, and deployment. You can benefit from a network that integrates with other specialized systems. LORENZ solutions are compatible with third-party software. This gives you the freedom to choose the perfect fit for you, even if it is not in the LORENZ portfolio.

Calyx understands that data is key to the success of any clinical development program. Your electronic data collection (EDC), system is crucial to your success. Calyx EDC is used in more than 2,600 clinical trials around the world. It streamlines data collection and reporting through one platform. Don't give your sensitive data to anyone. We can help you make your program a success with Calyx. Calyx EDC allows you to plan, design, and carry out studies of any complexity. Calyx EDC helps you keep your trial on track with features that reduce costs, improve site visibility and drive efficiency.

Emergo by UL's Regulatory Affairs Management Suite (RAMS) is a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for medical device and in vitro diagnostic companies. RAMS, which is based on decades of regulatory compliance experience, offers a set of tools that help navigate the complex and ever-changing landscape of global medical devices regulations. Smart Builder is a tool which provides step-bystep guidance, templated text, and accurate regulatory documentation to facilitate smoother device registration. The Registration Tracker automates global registrations and certificates, helping organizations to avoid missed renewals and maintain their compliance.

The RecordPoint Data Trust platform helps highly regulated organizations manage data throughout its lifecycle, regardless of system. We work with organizations in highly regulated industries to ensure their data is right where it should be - safeguarded for privacy, security, and governance.

OpenText™, a leading provider of information management solutions for life sciences organizations, helps them to harness insights from data and content to improve their decision-making and accelerate product development. Integrate, manage and securely exchange data between people, systems, and things. Use information assets to drive innovation and commercialization. Cloud-native software can run anywhere, giving you freedom of choice. OpenText for life sciences accelerates discovery by delivering actionable insights that can be used to drive innovation in pipelines. Intelligent capture allows you to capture and manage research papers in electronic lab notebooks. Text mining can help you gain insights. Unstructured text in clinical trial reports, study protocol, clinical safety and efficiency findings, can be used to extract knowledge. Learn how to intelligently analyze and classify clinical trial documents and extract them to reduce the risk for costly stops and starts.

TopSource Worldwide experts in each country can help you manage and hire your international employees. Our in-country specialists ensure that all of your international HR and Payroll needs are met through our end-toend services. Real people with accurate employment advice. Service that is fast, reliable, and responsive with SLAs that are robust. Supporting all phases of the employee lifecycle from hiring to retirement. Account management centralized with a single contact. Access local HR and payroll experts at every location. You can hire new global talent within days, not weeks. All your needs will be met by a dedicated team of employment specialists. All your hiring needs can be met by a single global tech platform. Easy-to-use platform that integrates seamlessly with your existing HR software. Our established entities can provide complete employment contracts and manage employee benefits. We manage compliance and the hiring & onboarding processes from payroll to termination if required.

SmartInsights™, Global Market Access Platform, is an online subscription service that allows you to quickly and easily find current, accurate, and complete regulatory requirements for global markets access. The interface is user-friendly and designed to help you achieve global compliance. Access to key regulatory data and information that is essential for the day-to-day management and strategic business decisions. This includes entering new markets and introducing new products. Access to the most current information about the regulatory landscape and new or updated regulations in your product category. The database is constantly updated to ensure you have the most current information. Access can be customized according to the country and product categories that you require.

Marcaria is the global leader in domain registration and trademark registration, with operations in more than 180 countries and territories. As an ICANN accredited domain registrar they offer registration for more than 1,200 extensions including country-specific domains and generic top-level (gTLD) domains. They offer domain registration, management and hosting services, as well as free email accounts, email forwarding and URL forwarding. Marcaria offers comprehensive trademark registration and protection, guiding clients through the whole process, from feasibility analyses and application submissions, to obtaining registration certifications. Marcaria also offers trademark monitoring services to detect potential infringements. Clients can manage their domain portfolios with ease and monitor trademark statuses using an intuitive online interface.

RQM+, a global service provider for medical technology, is focused on accelerating market success and compliance. We deliver specialized solutions to medical technology companies and accelerate the journey along the entire product lifecycle, from concept through commercialization and post-market. Our portfolio of services allows us to deliver end-to-end products and solutions throughout the entire medical device lifecycle. RQM+ quality assurance engineers review materials lists, establish suppliers, and support design change processes. RQM+’s design quality engineers support any packaging, sterility or biocompatibility testing that may be required. RQM+ regulatory affairs consultants offer guidance and assistance with submissions to FDA, notified authorities, or other government agencies. Our extensive experience with the most recent reimbursement requirements and value based compensation models is what we use.

Gov2biz is an integrated regulatory agency management system that brings together all your licensees, employees, rules, regulations, data and documents onto one platform. Software that powers the government is delivered via a cloud-based platform designed exclusively for the government. Online applications, issuances, renewals and amendments, assessments, reporting, aggregation and reconciliation, payments. Everything is centralized. Controls and regulatory controls. A complete feature set to regulate product labels, registration and branding. A complete case management solution for law-enforcement organizations. Complete hub of easy to use software solutions for local government. Gov2biz is an SaaS-based cloud-based platform for regulatory agency management. Gov2biz has all the regulatory functions you and your licensees need in one place. Gov2biz adapts to all screen sizes.

The cloud-based platform automates all aspects of on-boarding and off-boarding. Global HR and payroll outsourcing in more than 100 countries. Local service delivery and expertise. You can manage your global workforce with built-in compliance and calculation capabilities. Global workforce management with one-stop HR and payroll services. We provide the best local support in 100+ countries, so you can concentrate on your business growth. You can scale your business worldwide without the complexity of multiple HR service providers. Our HRMS platform includes built-in compliance capabilities and is supported by Payroll and HR experts in each country. Our cloud-based platform is ISO-27001 certified and allows you to manage all aspects of your HR and payroll processes. You can access our global network of 100+ countries from anywhere in the world to support your business 24/7.

With meddevo, each team member has a workspace where they can create, manage and automate technical documentation of medical devices and IVDs. A turnkey SaaS. Run Changes, CAPAs, complaints and custom processes directly in the system. Due to the full eQMS/eTD sync, you will gain maximum insight. Reduce the administrative burden and process time to a minimum.

The Compliance Suite platform is a powerful and flexible technology solution that aids in the preparation and submission for the Securities and Exchange Commission's forms N-PORT, N-CEN and N-MFP. It also assists with other regulatory filing requirements such as Annex IV of AIFMD and CFTC and NFA Form PQR. It provides robust risk management, performance monitoring, pipeline and relationship tracking, as well as robust risk management. This easy-to-use, scalable solution is intuitive and simple to use. It also allows for the flexibility necessary to adapt to today's changing regulatory, business, and risk landscapes. The user-definable architecture of Compliance Suite allows it to be used for other value-added purposes beyond regulatory filing. Data repository for investor reporting and internal risk management. Features user-definable dashboard and fund performance charting functionality.

Transform your applications to ensure local compliance and security. While still using the cloud, map your controls and improve compliance programs. Your custom apps can be made to comply with data residency requirements without any additional development. You can enter new markets and increase revenue without affecting your customers' experience. InCountry ensures that your financial services applications are compliant with data regulations in more nations, so you can get the most out of them. A modern data compliance platform will help you protect your path to precision medicine. InCountry offers healthcare-focused solutions that can accelerate research and time to discovery. You can enter new markets and increase revenue without affecting your customer experience. InCountry ensures that your sales process is compliant with local data regulations.

STEMSOFT, a leader in medical informatics and a leading provider of end-to-end solutions for information management, regulatory compliance, and quality assurance to cell therapy manufacturers, hospitals-based cell therapy programs and family and public cord-blood banks, is a market leader. We empower healthcare providers by creating innovative software that helps them discover and deliver effective treatment. You can access training programs with proven results and value-added services. Qualified industry experts and resources provide you with the expertise and specialist knowledge that you need. STEMSOFT Certified Partners provide complementary products and services that streamline your daily workflow and help you meet regulatory and accreditation requirements.

Ennov Regulatory Suite is a world-class solution for regulatory content and information management. It is a unified, centralized and end-to-end solution that supports the regulatory information workflow, from the earliest stages through market authorization. This is a common principle that companies who strive to achieve regulatory operational excellence share. This is because they know that such a solution will allow them to drive harmonization and promote standardization, improve collaboration and ensure compliance, eliminate waste and reduce costs, accelerate product releases, and allow them operate and compete in global markets more effectively. Ennov Doc, Ennov Dossier, and Ennov Process combine to provide support for the entire regulatory product cycle, from early planning of registration targets to product retirement. The Ennov Regulatory Suite is a valuable tool for planning regulatory activity.

Transform the way you meet your regulatory and compliance reporting obligations. We are a team made up of regulatory experts, data engineers, and technology developers who are focused on improving the quality of data and finding new solutions for complex regulatory challenges. Our award-winning solutions help clients in the financial services sector, from boutique asset managers to tier-one banking, meet regulators' demands. Get accurate, complete and timely regulatory reports. Search, share and manage regulations on a single digital platform. Automated reporting and monitoring of shareholding disclosure. A holistic approach to managing market abuse and misconduct. Automated research management reduces regulatory risk. Accredited training on a variety of regulatory reporting regimes. We are regulatory and information specialists on a quest to revolutionize how people work with compliance.

Global Expansions' Employer of Records service allows you to streamline your global operations and save money. It allows you to reduce the cost of HR, legal, and finance personnel while still maintaining compliance. You can say goodbye to expensive infrastructure setup costs in your country. Global Expansion's EOR platform allows you to hire legal, full-time employees in a new country quickly without the need to establish a local entity. Although the worker may appear to be employed by us on paper, they are actually working for you. Our platform automates compliance to protect your company and you. It is difficult to manage an international workforce. Our HR experts are located all over the globe and will be there to help you every step of your way. We make sure that you can quickly and confidently onboard new team members in foreign countries.

Our tailored, comprehensive regulatory solutions take the stress out KYC & AML compliance. Management and compliance assistance. Protect, maintain, and improve your brand. Trademark registration, oppositions, and defense, brand audit & protection. UK & Worldwide company formation & management services, cost-effective legal solutions, UK accounting & audit, company secretary and compliance assistance. We also have a large database of companies so we can provide information and documents from all countries. This is why our customers choose us.

No matter how experienced or novice you are with the regulatory submission process, you should not take the risk of your electronic common technical documents (eCTDs) being rejected lightly. This is especially true given the evolving regulatory environment. There are also differences in eCTD submission requirements by region. This makes it difficult to manage the entire document lifecycle and meet your organization's goals for accelerating your release to market. Certara's GlobalSubmit™, eCTD submissions management program, will give your regulatory team the tools to publish, validate, review, and approve your eCTD submitted documents. You can reduce risk and avoid unnecessary steps by using a simplified eCTD submissions process that supports your regulatory department as they race to meet deadlines to deliver treatment to patients. It is crucial that your eCTD submissions are filed as your regulatory department races for treatment delivery and deadlines.

Welcome to Yordas Helix - our proactive system for managing product risks and regulatory intelligence. Helix helps you gain control over market access, change and transparency in your global supply chains. Helix, a reflection on our company values and a solution that combines our scientific and industrial knowledge with our collaborative spirit, is a unique way to help you overcome regulatory challenges. We want to give you a platform that is easy to use and tailored to your business needs. Helix is not just a name, it's also a symbol for our commitment to data-driven innovations. It combines our expert consulting with a digital interactive solution to provide unparalleled insight into chemical compliance and risk. Helix combines your product data with our regulatory experience and compliance information to empower you to evaluate the impact on your products and your business.

BrightInsight speeds up the time to market of our customers' digital products. This includes apps, algorithms and medical devices, connected combination product products, diagnostics and Software as a Medical Devices (SaMD) across therapeutic fields. BrightInsight eliminates the need to 'build from scratch' lengthy and complex implementations. Instead, BrightInsight offers a pre-built, proven digital health platform that is designed under a Quality Management System. This supports global security, privacy and regulatory requirements. We assisted Roche in launching a Software as a Medical Device for hemophilia (SaMD), dosing calculator for hemophilia B in 6 months in Europe. We also accelerated a Top 10 Biopharma company remote patient platform from project kickoff through to commercialization in less that a year. We are experts in building and maintaining digital health products that are regulated by biopharma and medtech.