Regulatory filings are a crucial step towards market approval, supplying important information about the drug’s safety, efficacy, quality, and manufacturing process. As one of the most experienced CDMOs in the therapeutic nucleic acid industry, you can rely on our regulatory expertise, quality assurance teams, technical support, and post-approval support to help you navigate the complex regulatory landscape.
Driven by our technical and regulatory experience, we provide support for CMC sections of the regulatory submission. Explore our key support services below.
Regulatory Support for Filing
Support in preparation of Scientific Advice Meeting
Technical writing of quality-related dossier sections (e.g., Module 3)
Review of dossier submissions (IND, IMPD, NDA, MAA, J-NDA, BLA...)
Timely preparation of responses to regulatory questions from authorities
Assistance for post-approval life-cycle management
Additional Support
Strategies for implementation of ICH M7 requirements & preparation of statements
Implementation and development of purge factor approach (Purge & Fate Assessment)
Support adapted to early- and late-development needs
