CEP (Certificate of suitability) and Drug Master File (DMF) support
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What it is:
Preparation and maintenance of regulatory files for APIs submitted to authorities.
Why it matters:
API documentation is essential for finished product registration and regulatory support.
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We provide end-to-end support for Drug Master Files (DMF) and Certificate of Suitability (CEP) review and submissions. Our expertise ensures accurate and compliant API documentation.
- DMF preparation and submission
- CEP / DMF review
- Lifecycle management and updates
- Regulatory correspondence
Facilitating smooth API approvals and supporting global product registrations.
DMF Preparation & Submission
Compilation, authoring, formatting, and submission of Drug Master Files to relevant regulatory authorities.
Lifecycle Management & Updates
Support for amendments, annual updates, deficiency responses, and ongoing dossier maintenance.
CEP / DMF Review
Detailed technical review of existing dossiers to identify gaps, improve quality, and ensure compliance.
Regulatory Correspondence
Management of authority queries, deficiency letters, responses, and communication support during review.
Our Core Support
- • API regulatory strategy and documentation planning
• CEP dossier compilation and submission support
• DMF gap analysis and technical remediation
• Variation updates and lifecycle maintenance
• Global regulatory compliance for API registrations
Industries We Support
Our experienced regulatory professionals combine global knowledge with practical execution strategies to help clients move faster, stay compliant, and enter markets with confidence.
Pharmaceutical Formulations
Active Pharmaceutical Ingredients (APIs)
We offer affordable IT solutions that help you reduce costs and improve your bottom line.
Managed IT Services
Herbal & Nutraceutical Products
