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Regulatory Services In India
· Pharmaceuticals Regulatory Services In India
- Audit preparation as per various regulatory requirements.
- Drug Master File (DMF) Preparation.
- Drugs Master File - Development, preparation, assembly of complete common technical documentation (CTD).
- Dossier Preparation according to country specific guidelines.
- Dossier- Development, preparation, assembly of complete common technical documentation (CTD).
- Preparation of responses to regulatory authorities, comment letters, and assessment reports.
- Provision of support for scientific advice meetings, representation to regulatory agencies and meeting planning.
- Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms.
- Preparation of analytical method validation for all type of pharmaceutical formulation.
- Preparation of various documents required for dossier preparation.
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