RegDocs365 provides affordable, compliant content management and eCTD publishing when you need It.

The Challenge

Consultants, contract research organizations, and small biotech companies have been submitting new drug and biologics applications in paper format. Since May 2017, the FDA requires that Drug Master File, Abbreviated New Drug Applications, New Drug Applications and Biological License Applications be submitted in eCTD format. Investigational New Drug applications from commercial sponsors must be submitted in eCTD format since May of 2018. Migrating from paper format to valid eCTD format, including electronic signatures compliant with 21 CFR 11, can be too expensive for early stage biotechs.

Our Solution

RegDocs365 is a pre-configured, validated system to manage documents and data electronically that complies with the eCTD mandate on a per user, per month, subscription basis. This way, you don’t have to invest in an expensive system and dedicated technical staff. You benefit from best practices gained through over 100 years of industry consulting experience. You access best-of-breed software for authoring, document management, and eCTD publishing when you need it.

RegDocs365 provides options for eCTD consulting and publishing services and eCTD templates in MS Word format. The systems are hosted in Court Square Group facilities in multiple 21 CFR 11 Qualified data centers.

Resources

Basic Capabilities

  • Qualified Microsoft based infrastructure including SharePoint and SQL Server

  • Content management system preconfigured to EDM Reference Model for regulatory submissions and Electronic Trial Master File (eTMF)

  • Submission-ready PDF renditions

  • Collaborative review and approval workflows

Advanced Capabilities

  • Configured for Trial MasterFile Reference Model (eTMF)

  • Submission management for IND, MDF, ANDA, NDS, BLA Submissions

  • Optional submission templates for eCTD document authoring

  • Optional eCTD publishing services and software

Working in partnership with e-SubmissionsSolutions.com

RegDocs365 – Qualified and Validated Solutions for Regulatory Submissions

RegDocs365 is:

  • The new turn-key content management solution aimed at helping teams of disparate researchers to author content for their submissions.

  • A SharePoint based system implemented on fully qualified infrastructure to host validated applications, including “submission bundles” consisting of EDMS and eCTD solutions, and is purchased on a monthly subscription basis.

  • RegDocs365 enables pharmaceutical, biotechnology and medical device companies to author, review, approve, collaborate, and publish submissions.

  • RegDocs365 offers best-of-breed authoring tools to enable teams to write quality submissions.

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Feeling ready to unload your IT burden?

Let’s start a conversation. (413) 746-0054