Dossier Preparation and Submission

  • Our support in regulatory affairs for regulated markets for dossiers preparation and Intellectual Property Rights to pharmaceutical companies.
  • Expertise in dossier compilation and submission for global Pharma Clients.
  • Team of qualified, lead auditors certified with experience from several multinational companies (MNCs) with technical expertise to ensure vendor compliance to ICH, ISO. UK-MHRA, MCC, TGA etc., in-house or other standards as required.


  • Investigational New Drug Applications (Drugs) – INDA.
  • Abbreviated New Drug Applications (Drugs) – ANDA.
  • New Drug Applications (Drugs) – NDA.
  • Product License Applications (Biologics) – PLA.
  • Bulk Pharmaceutical Manufacturers (APIs) – DMF.
  • Bio Equivalence Testing Facilities.