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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

BeeCTD offers a comprehensive eCTD management system tailored for pharmaceutical companies and regulatory bodies. With its modular design and clear licensing approach, users can select the specific modules they wish to utilize, such as Reader, Compiler, and Validator. The advanced Reader provides insights into the complete lifecycle of the dossier, accommodating both eCTD and NeeS sequences, and facilitates the transition between the two formats, including baseline submissions. Additionally, the real-time sequence validator ensures compliance with the eCTD/NeeS technical specifications, incorporating best practices, while always reflecting the latest validation criteria, with older versions accessible for reference. Users can seamlessly compile their documents into an eCTD-compliant format, leveraging our eCTD compiler tool, which they can use independently or as an on-demand service where we handle the compilation for them. Moreover, the flexibility and scalability of BeeCTD make it an ideal choice for organizations seeking to enhance their regulatory submission processes.

Description

RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Montrium Connect No 

Integrations

Montrium Connect Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Altamira

Founded

2009

Country

Slovakia

Website

www.altamira.ai/beectd/

Vendor Details

Company Name

Montrium

Country

Canada

Website

www.montrium.com

Product Features

Product Features

Document Management

Access Controls No 
Archiving & Retention No 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing No 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management No 
Full Text Search No 
Offline Access No 
Optical Character Recognition No 
Print Management No 
Version Control Yes 

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