mobirise.com

Supportive Services

MYdossier is an Indian based Export dossier registration consulting firm. We offer a wide range of services in the areas of in the areas of writing & review of dossier, dossier sale, regulatory affairs consultancy, handling MOH inquiry, and dossier training for small to medium size pharmaceutical companies to help them to overcome the challenges within the rapidly evolving global pharmaceutical market. MYdossier is a global leader in regulatory consulting and dossier solution for export registration. We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline).

We are providing below services:
- SmPC, PIL, Label and pack insert - writing / review as per MOH guideline
- Translation of documents (in 50+ languages)
- Product literature and Readablity testing
- Artwork Desiging
- Patent services
- BA/BE studies - monitor and co-ordinate (with CRO)
- Process validation, Product Development and stability studies - protocol, report and chromatograms
- Strategic planning


We are having more than 30 associates for providing supportive services.