API Solutions

Regulatory

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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

  • Research and development plan on CMC, non-clinical, and clinical for 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
  • The relevant annual report amendment and supplement documents preparation

Inspections

  • Inspection document preparation 
  • On-site inspection assistance
Asymchem Regulatory Process