OUR ACTIVITIES

Medicines Regulatory Consultancies
Medicines Regulatory Consultancies
  • Product Dossier Compilation
  • Local representation for foreign holder of certificate of registration (HCR)
  • Product choice focused on local needs and emerging markets
    • Medical Supplies and Consultancy Services
    Medical Supplies and Consultancy Services
  • Procurement and supply of medical supplies to both public and private entities such as Central Medical Stores and private clinics and hospitals.
  • Compilation and submission of tender documents for both local and foreign bidders
    • Pharmaceutical Supplies and Consultancy Services
    Pharmaceutical Supplies and Consultancy Services
  • Procurement and supply of pharmaceutical supplies to both public and private entities such as Central Medical Stores and private clinics and hospitals.
  • Compilation and submission of tender documents for both local and foreign bidders
    • New Product Authorisations

      New Product Authorisations

      Presubmission technical data reviews | Gap Analysis | Regulatory Content authoring | Dossier compilation, validation and final submission of new product authorization applications for global filing | Review Gap Analysis & Remediation Advisory | Dossier Authoring - CMC Sections & Summaries | Biowaiver Justifications | SmPC/PIL/PI authoring/Reviews | Agency Query responses

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    • Post Approval Life Cycle Management

      Post Approval Life Cycle Management

      Response to agency queries/notices on marketed products | Variations | Manufacturing Site Transfers | Risk Assessments | Compliance and renewals

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    • Pharmacovigilance Services

      Pharmacovigilance Services

      Drug safety services | Collates, processes and compiles relevant safety information from all sources, including individual cases, published literature and clinical studies

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