Drugzsphere
Quality & Compliance

Quality isn't a section.
It's the deal.

Every product we ship comes with the regulatory paperwork your local authority needs — verified, formatted and translated for your market.

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.

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 dataZone IVa / IVb
Method validation reportsOn request
Serialisation & track-and-trace dataWhere required
Product / registration documents
Certificate of Pharmaceutical Product (COPP)CDSCO issued
Free Sale Certificate (FSC)Available
CTD / ACTD dossierCompiled per market
Drug Master File (DMF)For APIs
Bioequivalence (BE) studiesWhere applicable
Artwork in local languageIncluded
05 — Country-level approvals

Local regulators we've already cleared with.

NAFDAC
Nigeria
FDA Ghana
Ghana
PPB
Kenya
TMDA
Tanzania
ANVISA
Brazil
COFEPRIS
Mexico
INVIMA
Colombia
SFDA
Saudi Arabia
MOH UAE
UAE
EDA
Egypt
FDA-PH
Philippines
DAV
Vietnam

Plus active dossier work for: Uzbekistan, Kazakhstan, Sri Lanka, Cambodia, Myanmar, Iraq, Yemen, Bolivia, Chile, Peru, Côte d'Ivoire, Senegal & more.

Want our full capability statement?

A 6-page PDF with plant approvals, dossier capability and reference markets. We share it under NDA.