Pharma export compliance checklist
Introduction
Exporting pharmaceuticals is a high-opportunity business—but without proper compliance, even the most promising deals can be delayed or rejected. International markets have stringent standards regarding product quality, safety, and documentation.
To help you avoid mistakes, Salvavidas Pharmaceutical has created a pharma export compliance checklist that ensures your shipments meet global standards.
Why a Compliance Checklist is Important
A single missing document or labeling error can cause:
- Shipment delays
- Financial penalties
- Loss of client trust
- Regulatory action
Following a well-structured checklist minimizes these risks and keeps your export operations smooth.
The Pharma Export Compliance Checklist
1. Verify Product Registration
Ensure that your product is registered and approved in the importing country according to its regulatory requirements.
2. Prepare Required Documentation
Common documents include:
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Analysis (CoA)
- Free Sale Certificate (FSC)
- Manufacturing License
- Commercial Invoice & Packing List
3. Follow GMP Standards
Work only with GMP-certified manufacturing facilities to meet international quality expectations.
4. Ensure Correct Packaging & Labeling
Packaging should comply with the importing country’s rules, including dosage information, safety warnings, and language translations.
5. Meet Export Licensing Requirements
Obtain necessary export licenses from the relevant Indian authorities (e.g., CDSCO, DGFT).
6. Plan for Temperature-Controlled Logistics
For sensitive products, ensure that the cold chain is properly managed from origin to destination.
7. Stay Updated on Country-Specific Rules
Regulations change often—regularly review requirements for your target export markets.
How Salvavidas Supports Compliance
We offer end-to-end regulatory and documentation support so pharma exporters can focus on business growth. Our services include:
- Dossier preparation (CTD/ACTD)
- Regulatory approvals & renewals
- Labeling and artwork checks
- Quality testing and certifications
- Logistics coordination
Conclusion
Compliance is the backbone of successful pharmaceutical exports. By following this pharma export compliance checklist and partnering with experts like Salvavidas Pharmaceutical, you can avoid costly mistakes, meet deadlines, and expand globally with confidence.
0