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

API Solutions