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Pharmaceutical Registration (including New Drug Application (NDA), Biologics and Generics)

Nyprax offers regulatory support for new chemical entity development, clinical trials, marketed products, generics, biosimilars, OTC products, as well as regulatory activities related to mergers and acquisitions.

We help to compile registration dossiers as per ASEAN Common Technical Dossier (ACTD) or International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) format, liaising with principals and the ministry to meet timelines. Nyprax will guide you on document requirements for local submission and assist in submitting the completed dossiers for you. Subsequently, we attend to ministry’s queries, including initial input requests until the completion of the evaluation process.

• Registering NDA/Generics be it Biologics or Chemicals
• Life Cycle Management of Recently Marketed Products
• Regulatory Maintenance of Older Products
• Post-Marketing Drug Safety & Pharmacovigilance
• Labeling Updates and Harmonization of Labels
• Product Transfers
• Product Acquisitions
• Company Mergers
• Company Acquisitions (regulatory due diligence)
• Regional Marketing Deals (co-promotion, co-marketing)
• Special Projects