Affordable, Compliant Content Management & eCTD Publishing

When You Need It

Challenge
Consultants, contract research organizations, and small biotech companies have been submitting new drug and biologics applications in paper format. In May 2017, FDA required that Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA) and Biological License Applications (BLA) be submitted in eCTD format. Investigational New Drug (IND) applications from commercial sponsors and Drug Master File (DMF) must be submitted in eCTD format in May of 2018. Migrating from paper format to valid eCTD format, including electronic signatures compliant with 21 CFR Part 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 0management, 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 Part 11 Qualified data centers.