Quality & Compliance
Quality isn't a section. It's the deal.
01 — Manufacturing standards
We only source from certified manufacturers.
No exceptions. Every plant we work with holds active GMP certification from a recognised authority, and we share scope-of-approval details under NDA before any commitment.
WHO-GMP
Baseline for every plant. WHO Good Manufacturing Practice — recognised across ROW.
EU-GMP
For select dosage forms (especially injectables) — plants approved by EU national authorities with QP release.
US FDA
Partner plants with active USFDA approvals and successful inspection history.
UK MHRA & PIC/S
Plants inspected under UK MHRA / PIC/S — strong signal for tender-heavy markets.
Products are made at partner manufacturing plants; specific approvals vary by plant and market. Every partner plant is WHO-GMP certified.
02 — Quality management
ISO 9001:2015 QMS
Documented procedures, audited annually, with batch-level traceability and deviation handling baked in.
- Vendor qualification & periodic audit
- CAPA & deviation management
- Customer complaint handling SOPs
- Annual product quality review (APQR)
03 — Distribution
WHO-GDP compliant logistics
Storage, transport and handling protocols modelled on WHO TRS 957 / EU GDP — including validated cold-chain for sensitive products.
- Ambient (15–25°C), cool (2–8°C) & frozen options
- Calibrated data loggers on cold-chain shipments
- FOB / CIF / DDP — your choice of Incoterm
- Serialised batch records for full traceability
04 — Documentation capability
The full paperwork stack — handled.
Most exporter sites don't tell you what documents come with the box. We do — explicitly, by product type and by market.
Batch-level documents
- Certificate of Analysis (COA)
- Every batch
- Batch Manufacturing Record (BMR)
- On request
- Stability data
- Zone IVa / IVb
- Method validation reports
- On request
- Serialisation & track-and-trace data
- Where required
Product / registration documents
- Certificate of Pharmaceutical Product (COPP)
- CDSCO issued
- Free Sale Certificate (FSC)
- Available
- CTD / ACTD dossier
- Compiled per market
- Drug Master File (DMF)
- For APIs
- Bioequivalence (BE) studies
- Where applicable
- Artwork in local language
- Included
05 — Country-level approvals
Local regulators we've already cleared with.
- NAFDACNigeria
- FDA GhanaGhana
- PPBKenya
- TMDATanzania
- ANVISABrazil
- COFEPRISMexico
- INVIMAColombia
- SFDASaudi Arabia
- MOH UAEUAE
- EDAEgypt
- FDA-PHPhilippines
- DAVVietnam
Plus active dossier work for: Uzbekistan, Kazakhstan, Sri Lanka, Cambodia, Myanmar, Iraq, Yemen, Bolivia, Chile, Peru, Côte d'Ivoire, Senegal & more.
Products are made at partner manufacturing plants; specific approvals vary by plant and market. Every partner plant is WHO-GMP certified.
Want our full capability statement?
A 6-page PDF with plant approvals, dossier capability and reference markets. We share it under NDA.