• 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.

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.