Dossier Preparation and Submission

  • Back office support in regulatory affairs for regulated markets including product development dossiers and Intellectual Property Rights to pharmaceutical companies.
  • Expertise in dossier compilation and submission for global Pharma Clients.
  • Meticulous review of the dossier ready-for-submission and support in regulatory due diligence.
  • 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.
  • Adept in e-communications and e-submissions and adherence to 21CFR11.

Expertise

  • 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