Besides clinical regulatory services, Indegene has an extensive track record of providing quality and efficient technical/non-clinical regulatory writing services to its clients.
Indegene has a robust understanding of CMC and allied services. These services are integrated, complex, and process-driven, with multiple stakeholders within the R&D, Regulatory, Supply Chain, and Commercial divisions. Indegene’s well-established Hybrid Off-site Delivery and Operations model is cost-effective, flexible, and seamlessly integrates with the needs of regulators and clients across the world.
Indegene has a pool of dedicated resources for regulatory activities who are experienced in global and regional submissions, CMC-related activities, and legacy documents to CTD format conversions, in addition to being well versed with various publishing tools.
CTD Mod 2.4 and 2.6: Non-clinical Overviews and Summaries
CTD Mod 4: Pre-clinical Study Report
CTD Mod 2.3: Quality Overall Summaries
CTD Mod 3: Quality Report
Updates to Approved Dossiers
Preparation of Type I/CBE -30, Type II/PAS, and Minor Variation Documents
Publishing: Document Assembly, Compilation, Publishing
Submissions: eCTD Filing, Global Paper CTD
Filings: IND/CTA, NDA/MAA
Legacy Conversion of CTD Dossiers
Customizing Completed Dossiers for Regional Submission