WHO-GMP Certification and the Certificate of Pharmaceutical Product (COPP) are essential for pharmaceutical manufacturers exporting medicines to international markets. Applications are submitted through the Online National Drugs Licensing System (ONDLS) in accordance with the Drugs and Cosmetics Act, 1940, Drugs Rules, 1945 and applicable CDSCO guidance. Vaayath provides comprehensive support for documentation, ONDLS filing, regulatory review and coordination with licensing authorities to facilitate timely approvals.
What We Deliver
- WHO-GMP Application Filing — Preparation and online submission of WHO-GMP applications through the ONDLS portal.
- COPP Filing — Preparation and filing of COPP applications for export markets.
- Documentation Review — Comprehensive review of GMP records, manufacturing licences and supporting documents before submission.
- ONDLS Portal Support — Registration, profile management, application filing and online compliance support.
- Deficiency Response — Preparation and submission of responses to regulatory observations.
- Export Product Assessment — Assessment of product eligibility and applicable regulatory requirements.
- Licensing Documentation — Verification of manufacturing licences, product permissions and regulatory approvals.
- Coordination with Licensing Authorities — End-to-end follow-up with State Licensing Authorities and CDSCO, wherever applicable.
- Post-Approval Support — Amendments, additional products, duplicate certificates and revalidation support.
- Regulatory Consulting — Strategic guidance for export certification and market-specific documentation requirements.
Our Approach
Regulatory Assessment
Review manufacturing licences, export requirements and eligibility for WHO-GMP or COPP.
Documentation Preparation
Compile, verify and prepare all supporting documents and application forms.
ONDLS Filing
Complete online submission through the ONDLS portal with continuous tracking.
Approval & Lifecycle Support
Coordinate with authorities until approval and provide support for future amendments and renewals.
Who this is for
Why Choose Vaayath
- Extensive Experience with ONDLS Filing
- WHO-GMP & COPP Documentation Specialists
- Regulatory Deficiency Management
- Export Regulatory Consulting
- End-to-End Filing Support
- PAN India Regulatory Assistance
- Timely Application Tracking