Regularotry support for cmc sections
IND/IMDP & NDA/MAA Filing Support
Regulatory filings are a crucial step towards market approval, supplying important information about the drug’s safety, efficacy, quality control, 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 CMC support for sections 1 through 7. BLA-filing assistance/support can also be offered. See below for a full list of our support services:
Regulatory Support for Filing
- Technical writing (and maintenance) of dossier sections
- Review of dossier supmissions (IND, NDA, BLA, DMF...)
Documentation Support for:
- E&L risk analyses for late stage of marketed products
- Nitrosamine assessments
- Comprehensive assessments or general statements for processes/products
Additional Support
- Developing strategies for implementing requirements of ICH M7 Guideline (Assessment and Control of DNA reactive impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk)
- Implementation and further development and improvement of purge factor approach
- Applied approach to other carcinogenic impurities
- Support for Tox assessments for APIs