Our Regulatory Services

V3 Life Care Exim has in-house regulatory expertise to manage pharmaceutical exports with complete compliance. We prepare and review regulatory documentation, dossiers, and export registrations according to the specific requirements of each destination market. Our team ensures that every export meets the regulatory standards of the importing country before shipment.

Dossier Solutions

We provide comprehensive dossier preparation and regulatory consulting for export registration. We write and review dossiers as per guidelines specific to each destination country's regulatory authority.

Regulatory Documentation

CTD (Common Technical Document)

  • Module-1 (Regional & Administrative Information)
  • Module-2 (Quality Overall Summary)
  • Module-3 (Quality)
  • Module-4 (Nonclinical Study Reports - Safety)
  • Module-5 (Clinical Study Reports - Efficacy)

ACTD (Active Pharmaceutical Ingredient Technical Document)

  • Part I (Administrative Data)
  • Part II (Quality Summary)
  • Part III (Non Clinical Overview Summary)
  • Part IV (Clinical Overview Summary)

Country-Specific Documentation

Regulatory requirements vary by market — in format, structure, and health authority standards. We prepare documentation aligned to your destination country's specific filing requirements, so your submission is compliant before it reaches the buyer.

Country Documentation

DMF (Drug Master File)

Open and Closed Parts

A Drug Master File (DMF) is a document prepared by a pharmaceutical manufacturer containing confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of APIs.

Content of DMF

  • General Information
  • Manufacture
  • Characterization
  • Control of Drug Substance
  • Reference Standards or Materials
  • Container Closure System
  • Stability

Bioequivalence (BE) Studies and Supporting Documentation

  • Analytical Method Validation / Verification (AMV)
  • Comparative Dissolution Profile
  • Stability Studies with summary reports
  • Expert Quality Report, Clinical and Non-clinical
  • Summary of product (SmPC) and Pack Information Leaflet (PIL)
  • Art Work
  • Clinical Trial Studies from DCGI approved labs
  • Reply to Ministry of Health (MOH) queries
  • Approvals / Products Permission / FSC

Regulatory & Compliance
Checklist

Products sourced from licensed and GMP-compliant manufacturing facilities
Manufacturing partners hold valid WHO-GMP / cGMP certifications (where applicable)
Compliance with Indian pharmaceutical regulations and export requirements
Batch-wise documentation and traceability maintained
Certificate of Analysis (COA) available for each batch
Quality documentation verified before dispatch
Export documentation support (Commercial Invoice, Packing List, COO, etc.)
Compliance with importing country regulatory requirements (subject to product registration requirements)
Support provided on pharmacovigilance and quality complaint documentation requirements
Coordination with manufacturers on storage and transportation compliance
Vendor qualification and periodic manufacturer assessment process
Manufacturer recall and corrective action procedures verified during partner assessment
Commitment to ethical business practices and regulatory compliance

If You Export
Nutraceuticals / Herbal Products

FSSAI-compliant manufacturing facilities (where applicable)
Compliance with destination country labeling requirements
Ingredient and specification verification
Stability and shelf-life documentation support

Ready to Export with Full Regulatory Support?

Submit your product inquiry and let our regulatory team prepare comprehensive documentation for your destination market.

Submit Inquiry