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.
- 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