WHO-GMP
Good Manufacturing Practices certification covering all four production blocks, granted by the State Licensing Authority following a full facility inspection.
ActiveRenewed 3-yearly
Certifications
Independently
verified, repeatedly
Certification is not a plaque on the wall — it is a live commitment re-audited every year by regulators, customers and our own QA.
Current certifications
Held, maintained and re-audited
Each of these is a live certification with a renewal date and a surveillance audit schedule. Copies are provided to qualified partners on request.
ISO 9001:2015
Quality management system certification covering design and development, manufacturing, quality control and distribution of pharmaceutical formulations.
ActiveAnnual surveillance
ISO 14001:2015
Environmental management system certification covering effluent treatment, solvent recovery, emissions monitoring and hazardous waste handling.
ActiveAnnual surveillance
GLP
Good Laboratory Practices compliance across our quality control and analytical development laboratories, including instrument qualification and data integrity controls.
ActiveLaboratory scope
Schedule M
Compliance with Schedule M of the Drugs and Cosmetics Rules covering premises, plant, equipment, personnel and documentation requirements.
ActiveStatutory
FSSAI Licence
Food Safety and Standards Authority of India licensing for the manufacture of nutraceuticals, health supplements and clinical nutrition products.
ActiveNutraceutical scope
Regulatory documentation
What we can issue you
Export and institutional partners routinely need these. All are prepared by our regulatory affairs team and issued against a written request.
| Document | Purpose | Issued by | Typical turnaround |
|---|---|---|---|
| Certificate of Analysis (CoA) | Batch-specific test results against specification | Quality Control | Same day |
| Certificate of Pharmaceutical Product (CoPP) | WHO-format certification for import registration | Licensing Authority | 4–6 weeks |
| Free Sale Certificate | Confirms the product is freely sold in the country of origin | Licensing Authority | 3–4 weeks |
| WHO-GMP Certificate | Confirms GMP compliance of the manufacturing site | Licensing Authority | On request (copy) |
| Drug Master File (DMF) | Confidential manufacturing and control details | Regulatory Affairs | 2–3 weeks |
| Process Validation Report | Evidence of consistent commercial-scale manufacture | Quality Assurance | 1–2 weeks |
| Method Validation Package | ICH Q2(R2) analytical method validation data | Analytical Development | 1–2 weeks |
| Stability Data Package | Accelerated and real-time data under the relevant ICH zone | Quality Control | 1–2 weeks |
| Site Master File | Facility overview for audit and registration purposes | Quality Assurance | 1 week |
| CTD / ACTD Dossier | Complete registration dossier for market authorisation | Regulatory Affairs | 6–10 weeks |
Audit readiness
Ready on any Tuesday
A facility that needs three weeks to prepare for an audit was not compliant during those three weeks. We hold documentation current continuously, which is why we can accept short-notice inspections.
- Site Master File maintained liveUpdated within 30 days of any material change to premises, equipment or organisation.
- Validation Master Plan currentEquipment, utility and process qualification status reviewed quarterly.
- Annual self-inspectionEvery department audited internally against GMP, with findings tracked to closure.
- Deviation files open to reviewWe do not curate which investigations an auditor may see.
0
Regulatory and customer audits hosted in the last three years.
0
Critical observations issued across those audits.
0
Standard notice period for a scheduled customer audit.
0
Observations closed within the agreed commitment date.
We asked to see a deviation file at random. Nobody hesitated, and nobody left the room to fetch a different version.
M. Thiam
Regulatory Lead, Import Partner · West Africa
Request certificate copies
Certification copies, CoPPs and audit documentation are issued to qualified partners against a written request from a registered business address.