API Solutions
Regulatory

Service and Support that Meets Regulations Worldwide
Asymchem’s regulatory affairs experts play a crucial role in every project from start to completion. As a fully integrated provider we employ our knowledge of scientific, business, and legal matters to ensure projects meet expectations of regulatory bodies worldwide. We take pride in our strong communication, cross-functional coordination, and experienced project management to provide our clients with high-quality and thorough services that lead to regulatory compliance.
Consulting Services
- CMC Research and Development Planning for IND and NDA Registration
- Global Registration Strategy Evaluation
- Agency Engagement on Registration Strategy
- Regulatory Intelligence
- Ad-hoc Consultation
Registration and Application Services
- Institutional meetings, including type 1,2,3 CDE consultation meetings
- Submitting meeting requests
- Preparing meeting documents
- Attending meetings to assist clients in communicating with regulatory agencies
- Gap analysis of CMC, non-clinical, and clinical parts of the archives in accordance with relevant regulations and guidelines
- IND / CTA application, NDA / BLA application; annual report and supplementary application
- Update and change of production license
- Monitor and follow up on review progress
- Provide regulatory support on GxP audits
- Quality systems assessment based on relevant guidelines
- Data integrity audits
- Third party audits
- NDA/BLA application
- License maintain including License renewal and all kinds of variation
- Monitor and follow up review progress ( including response to any oral/formal questions and deficiency letters from agency with agreement of clients)
- API, excipient, and package material registry
- Sample testing
- Due diligence report
Composing and Filing
- Compose documents for IND, NDA and ANDA application
- Relevant annual report amendment and supplement documents preparation
Inspections
- Inspection document preparation
- On-site inspection assistance
