- Compilation of dossier as per latest country specific guidelines
- Our core focus is to offer supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Registering Pharmaceutical Dossier Writing. We have been involved with all aspects of regulatory affairs, from supporting Clinical trials, bioequivalence reports, validation data, Expert reports, Data for Overview, PSUR through registration activities, compilation of Pharmaceutical dossier / application for registrations of medicines and E-Filings to post-marketing regulatory obligations for Pharma Industry
Our Services Include:
- Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format).
- Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
- Expert reports on Quality ,Pre-clinical and Clinical
- Orphan Drug Application Preparation.
- Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
- Assistance in Response to queries for submission to the Regulatory Agencies.
- Periodic Safety Update Report (PSUR) preparation.
- Complete stability programme management service is provided as per ICH guidelines / special requirements in a cGMP and GLP compliant environment.
- Monitoring and liaising with the CRO’s for Clinical and BE Studies.
- Preparation of Site Master file