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Product Registration Support

ClinChoice prepares and manages legal documents to new product and renewal registrations with an eye for detail and deep knowledge of global and regional regulations.

The ClinChoice Product Registration and Legal Documentation team is experienced in preparing legal documents required for new registration and registration renewals. The team’s extensive knowledge of regulatory requirements of mature and developing markets form the foundation for the preparation of legal and administrative documents.

ClinChoice supports the creation of legal and non-legal documents for new registrations, renewals, tender participation, and technology transfer, among other requirements.

Our service offerings include:

  • Preparation and review of legal documents, including:
    • LOA
    • POA
    • LOD
    • Undertaking declarations
    • Formula pages
    • One group certificates
    • Manufacturing agreements
    • QA certificates
    • BSE
    • GMP
    • FDA print screen
    • Third-party attestations
    • Explanation letters
    • ISO certificate
  • Coordination with cross-functional teams for Labels and COA’s of API, Excipients, and Finished Product
  • Coordination with cross-functional teams, manufacturing site, and local affiliates for the required information to process the documents
  • Maintain work instructions and templates as needed
  • Sourcing finished product samples, reference standards, and API from manufacturing sites and distributing centers
  • Manage legalization through consular services
  • Processes regulatory request by acting as a liaison with the requester, supplier, and consular services
  • Liaise with the manufacturing sites and PCO to obtain information for regulatory submissions
  • Support coordination and legalization of ad-hoc regional ancillary documents
  • Support product portfolio through execution of legal document activities on existing and, as required, new product registrations in APAC, Latin and Central America, Caribbean, and EMEA region