Finished Products: Drugs/Herbal/ Nutritional Supplements/OTC
Regcure Pharma India provides proficient solutions to make accurate submissions using available data and Documents, with well-organized technical writing and submission for our clients globally.
Regcure Pharma will help you sail through complex requirements with ease. We can help with the following Regulatory Activities:
- Dossier preparations and New Product Development: Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format). Assistance in Administrative documents, Submission with MOH, and Post submission Support/Handling of Queries.
- Active Substances: DMF/ASMF/CEP: Regcure Pharma provides proficient solutions to make accurate submissions using available data and Documents, with well-organized technical writing and submission of DMF/ASMF for our clients globally.
All documents and data required for the DMF submissions are evaluated and aligned as per the international requirements and guidelines. We offer customized services for advice and complete project management for filing of:
Applicants (Open) Part DMF & Restricted (Closed) Part DMF
CEP: EDMF/ASMF (Applicants and Restricted Part) for EU.
- Clinical Services:
Preclinical and clinical overviews writing through literature search / published studies/articles from journals from different sources.
Across your drug development journey, our clinical services are a hub for all from managing and monitoring Clinical trials in a wide range of therapeutic areas and monitoring BE studies in India, aid in medical writing and Clinical studies, Bioavailability and Bioequivalence Studies, Clinical Trial Studies, Analytical Solutions, Prepare Periodic Safety Update report (PSUR), Risk management Report (RMP) and Preclinical studies like Toxicity, Carcinogenicity, and Teratology & Reproduction toxicity to Therapeutic Justifications for FDCs.
We will help you ensure regulatory compliance, boost competence, and lessen costs considerably.
- Other Services:
Prepare a summary of product characteristics (SmPC), Pack Insert, and Product rationale.
Provide analytical support in analytical method development/validation, Routine analyses of products by HPLC/GC/MS/UV/Titration, etc.
Preparation of Site Master file
Compilation of dossier as per latest country-specific guidelines