Technical And Non-Clinical Regulatory Writing

We assist you with timely submissions and high quality documents, hence eliminating the time taken for resubmission, resulting in time saving to bring the drug to market.


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.
 

Indegene's Suite of Technical and Non-clinical Regulatory Writing Service Offerings Include:

 

  • 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

  • CMC Document

  • Annual Reports

  • 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

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