At Meditree we have expertise to create dossiers for registration of Pharmaceutical Formulations, Medical Devices and other regulated products for Regulated Markets, Lesser Regulated Markets and Emerging Markets.
Meditree having a backing of product development labs have a bank of dossiers for many markets and also undertakes preparation of a technical dossier on specific request.
HOW WE CAN ASSIST :
- Dossier in CTD (modules 1 – 5 or any requisite module) and eCTD formats for worldwide markets like EU, USA, UK,
- Preclinical and clinical Overviews / Summary writing based on literature search / Published studies / articles from journals .
- Dossiers for ASEAN and ROW countries in ACTD/ as per country specific format.
- Evaluation of existing dossier for its adequacy in respect to a particular country
- Product information updates (SmPC, PIL and Labeling).
- Preparation of Drug Master File and Certificate of suitability (open and closed part)
DOSSIER REVIEW AND MAINTENANCE
- Review by counterparts in Europe of dossiers prepared for registration in EU/UK.
- Dossier review by special teams for other markets
- Provide EU-QP services for Pre-clinical and Clinical modules.
- Handling of all types of variations (Type Ia, Ib and II), annual reports, renewals of MAAs and support in query responses.