Regulatory Affairs Services for Finished Pharmaceutical Products
Regcure Pharma India offers expert regulatory solutions to support accurate submissions using existing data and documentation. Our team ensures well-structured technical writing and streamlined submission processes for clients worldwide.
Our Pharmaceutical Regulatory Affairs Services Include
Dossier Preparation & New Product Development
- Preparation and submission of registration dossiers to global regulatory agencies in eCTD, CTD, and ACTD formats.
- Assistance with administrative documents, submissions to Ministries of Health (MOH), and post-submission support including query resolution.
Active Substance Regulatory Services (DMF / ASMF / CEP)
We specialize in preparing Drug Master Files (DMF), Active Substance Master Files (ASMF), and Certificates of Suitability (CEP):
- Evaluation and alignment of documents and data per international regulatory guidelines.
- Customized support for open (applicant) and closed (restricted) parts of DMFs.
- Preparation of EDMF / ASMF for CEP submissions to the European Union.
Clinical Regulatory Services
Our clinical regulatory support spans the entire drug development journey:
- Preclinical and clinical overviews through in-depth literature reviews and journal analysis.
- Management and monitoring of clinical trials across therapeutic areas.
- Support for:
- Bioavailability (BA) and Bioequivalence (BE) studies
- Clinical Trial Studies
- Analytical solutions
- Medical writing
- Periodic Safety Update Reports (PSUR)
- Risk Management Plans (RMP)
- Toxicology studies (Carcinogenicity, Teratogenicity, Reproductive toxicity)
- Therapeutic justifications for Fixed Dose Combinations (FDCs)
We help you ensure regulatory compliance, improve operational efficiency, and reduce costs.
Additional Pharmaceutical Regulatory Services
- Preparation of Summary of Product Characteristics (SmPC), Package Inserts, and Product Rationales
- Analytical support for method development and validation
- Routine product analysis using HPLC, GC, MS, UV, titration, and other techniques
- Site Master File preparation
- Dossier compilation per latest country-specific guidelines
Why Choose Regcure Pharma for Regulatory Affairs Services?
✅ Global Expertise
✅ End-to-End Regulatory Support
✅ Cost-Effective, Compliant Solutions