Approved
WHO-GMP
WHO Good Manufacturing Practice
Manufacturing site inspected and approved under WHO-GMP framework. Renewals maintained on schedule.
World Health Organization
Quality & RegulatoryReady for audit.
Ready for audit.
Every quarter.
WHO-GMP inspected, MHRA-aligned, cGMP throughout. Our regulatory affairs team prepares dossiers in-house — the chemists doing the work also answer the reviewer's questions.
WHO-GMPMHRA alignedcGMPISO 9001ISO 14001ICH Q7ICH Q9ICH Q10ICH Q1B stabilityUSPEPJPWHO-GMPMHRA alignedcGMPISO 9001ISO 14001ICH Q7ICH Q9ICH Q10ICH Q1B stabilityUSPEPJP
Quality record
The numbers behind the posture.
0%
Inspection pass rate
8 yrs · all inspections
0
Critical findings
in 8 years
0/7
QC coverage
in-line + release testing
0.6%
First-pass QC release
commercial API supply
Certifications & alignments
Every credential, verifiable.
Certificate copies are provided under NDA to serious buyers. Inspection reports (including minor observations) are shared during due diligence.
Aligned
MHRA aligned
MHRA-aligned framework
Quality system aligned to UK MHRA expectations. In-house RA team has hosted MHRA inspectors.
UK Medicines & Healthcare Regulatory Agency
Aligned
cGMP
Current Good Manufacturing Practice
Batch records, deviation logs, CAPA closure, and change control aligned to current cGMP norms.
US FDA framework
Verified
ISO 9001
Quality Management System
ISO 9001:2015 quality management system covering the manufacturing site.
International Organization for Standardization
Aligned
ICH Q7
GMP for Active Pharmaceutical Ingredients
API manufacturing operations aligned to ICH Q7. All commercial molecules manufactured under this framework.
International Council for Harmonisation
Aligned
ICH Q9
Quality Risk Management
Risk management processes for deviations, change control, and CAPA aligned to ICH Q9 principles.
International Council for Harmonisation
Aligned
ICH Q10
Pharmaceutical Quality System
Quality system spans the full product lifecycle from development through commercial supply.
International Council for Harmonisation
Verified
ICH Q1B
Photostability Testing
Photostability chambers and protocols per ICH Q1B for every commercial product.
International Council for Harmonisation
Inspection history
Every audit on the record.
A partial record of regulatory, client-led, and third-party audits over the last several years. Full inspection reports available on request under NDA.
- Year2024Renewal
WHO-GMP renewal inspection
Approved · zero critical, three minor observations closed
- Year2023Client audit
Client-led audit (EU specialty pharma)
Passed · one minor observation closed same quarter
- Year2023Third-party
MHRA-alignment third-party audit
Aligned · gap analysis actioned
- Year2022Regulatory
WHO-GMP inspection
Approved · zero critical, five minor observations closed
- Year2022Client audit
Client-led audit (APAC generics)
Passed · zero observations
- Year2021Regulatory
WHO-GMP inspection
Approved · zero critical
Full reports on request. Serious buyers evaluating a supply relationship can request the full text of any inspection report — minors and majors included — under NDA.
Regulatory affairs
In-house dossier team.
Our regulatory affairs team writes every dossier we submit, in-house. No outsourced medical writers, no third-party bridge documents. When a reviewer has a question, the person who wrote the answer picks up the phone.
See CDMO capabilities- CTD / eCTD / ACTD dossier preparation
- DMF and CEP submissions
- Country-specific registration
- Post-approval variation filings
- Nitrosamine risk assessment per ICH M7
- GMP inspection preparation & hosting
Compliance philosophy
Four things we believe.
01
Audit-ready every day, not on demand
Batch records are complete within one shift, not on inspection eve. Deviation investigations kick off within 24 hours. The QA head can produce the last twelve months of quality events from a single query.
02
Own the deviation before someone finds it
Deviations are opportunities to improve, not blemishes to hide. We report our own to clients before they find them. Speed matters more than optics.
03
Human sign-off on every batch
QA sign-off is a named person on every batch record. Not automated. Not delegated. Not rubber-stamped after the fact.
04
Dossiers prepared in-house
Our regulatory affairs team prepares CTD, eCTD, and ACTD dossiers directly — no outsourced writing shops. The chemists doing the work also answer the reviewer's questions.
Serious about regulatory posture?
Read our long-form article on what MHRA inspectors ask, and how we prepare.
Regulatory-first CDMO
Talk to a regulatory lead.
For confidential regulatory conversations — dossier review, inspection preparation, or a specific market entry question — reach our RA lead directly through the contact form.