Dhaka, BangladeshGMP & ISO Certified Manufacturer
REGULATORY AFFAIRS
Filed, approved, and trusted across 34 markets.
We manage the full regulatory lifecycle — dossier authoring, submission, queries, variations, renewals — for every molecule we ship.
APPROVED
DGDA
Bangladesh
APPROVED
WHO-PQ
Geneva
APPROVED
MOH-KSA
Riyadh
APPROVED
PPB
Kenya
APPROVED
NAFDAC
Nigeria
34
Export markets
412
Active registrations
96%
First-cycle approval
< 30d
Query response SLA
MARKET COVERAGE
Registered where patients need us.
South Asia
BangladeshSri LankaNepalBhutanMyanmar
MENA
Saudi ArabiaUAEYemenIraqSudanLibya
Africa
KenyaNigeriaGhanaTanzaniaUgandaEthiopiaZambia
Southeast Asia & CIS
VietnamCambodiaPhilippinesKazakhstanUzbekistan
REGULATORY OPERATIONS
INSIDE THE RA DESK
18 regulatory specialists. 24-hour turnaround on agency queries.
CTD DOSSIER CAPABILITY
We author every module in-house.
M1
Administrative & Regional
Application forms, cover letters, agency-specific annexes.
M2
CTD Summaries
QOS, non-clinical & clinical overviews and summaries.
M3
Quality
Drug substance, drug product, specifications, stability packages.
M4
Non-clinical Study Reports
Pharmacology, PK, toxicology reports where applicable.
M5
Clinical Study Reports
BE studies, clinical data, literature references.
SUBMISSION LIFECYCLE
From gap analysis to marketing authorization.
01
Gap Analysis
02
Authoring
03
QC Review
04
Submission
05
Query Response
06
Approval
AGENCIES WE WORK WITH
Direct filings, no intermediaries.
DGDA
Directorate General of Drug Administration · Bangladesh
412 registrations
WHO-PQ
WHO Prequalification Programme · Global
4 products prequalified
SFDA
Saudi Food & Drug Authority · Saudi Arabia
28 registrations
PPB
Pharmacy & Poisons Board · Kenya
41 registrations
NAFDAC
National Agency for Food & Drug Admin. · Nigeria
36 registrations
DAV
Drug Administration of Vietnam · Vietnam
17 registrations
PV UNIT · 24×7
PHARMACOVIGILANCE
Signals we watch, reports we file.
ADR intake
Literature screening
PSUR / PBRER
Risk management plans
Signal detection
Expedited reporting
POST-APPROVAL LIFECYCLE
Variations, renewals, and change control.
Type IA
Minor notifications
Immediate implementation, notified within 12 months.
Example — Manufacturer address name change.
Type IB
Minor variations
Filed and approved by tell-and-do or 30-day review.
Example — Shelf-life extension backed by data.
Type II
Major variations
Prior approval required — full assessment cycle.
Example — New strength or new indication.
2026 REGULATORY CALENDAR
What's on the desk this year.
Q1
- DGDA renewals x 84
- SFDA new filing — 2 SKUs
Q2
- PPB variations x 12
- WHO-PQ dossier update
Q3
- NAFDAC renewals x 22
- DAV new market entry
Q4
- Annual PSUR cycle
- MOH-Iraq site inspection
REFERENCE LIBRARY
Public regulatory documents.
For partners, health authorities, and institutional buyers. Confidential CMC and clinical packages are shared under NDA.
GMP Certificate — DGDA
PDF · 640 KB
WHO-PQ Public Assessment Reports
PDF · 3.2 MB
Site Master File (public extract)
PDF · 1.8 MB
Pharmacovigilance Policy
PDF · 220 KB
Free Sale Certificate — DGDA
PDF · 410 KB
CPP template (specimen)
PDF · 180 KB
PARTNER WITH REGULATORY AFFAIRS
Planning a new market entry? Let's file it right the first time.
We author, submit, and defend dossiers in 34 jurisdictions. Send us the molecule and target markets — we'll return a filing plan in 10 working days.