Uni-Pex Pharmaceuticals Pvt. Ltd.
Regulatory Affairs

The team that gets your brand across borders.

CTD/eCTD dossiers, CoPP issuance, product registration and GMP audit support — engineered entirely in-house. 150+ export-ready dossiers, zero third-party consultant dependency.

WHO-GMPCertified plant
Since 199925+ years
5 ContinentsMarkets supplied
CTD / eCTDIn-house dossiers
150+ Registrations
CoPP Ready
CTD / eCTD DOSSIERSCOPP ISSUANCE PRODUCT REGISTRATIONSTABILITY ZONE IVb GMP AUDIT SUPPORTWHO-GMP CERTIFIED CTD / eCTD DOSSIERSCOPP ISSUANCE PRODUCT REGISTRATIONSTABILITY ZONE IVb GMP AUDIT SUPPORTWHO-GMP CERTIFIED
Why It Matters

Regulatory isn't a back office here. It's where we win business.

For an importer, the manufacturer is the easy part — the paperwork is what kills timelines. We removed that risk by building the entire regulatory function in-house: every dossier, every certificate, every stability study engineered under our own roof, accountable to one team.

"Compliance isn't a checkbox — it's our culture."

0
Ready Product Dossiers
0
Regulatory Professionals
0
In-House Dossier Preparation
0
Continents Supplied
Our Core Capabilities

Support at every stage of approval

One in-house team owns your dossiers, registrations and audits — so your products clear customs and health authorities without legal delays.

01

Dossier Preparation (CTD/eCTD)

100% internal engineering of technical dossiers to international and domestic health-authority requirements.

02

Product Registration Support

Direct, active support for importing partners to obtain fast distribution licenses for your brand.

03

Certificate of Pharma Product (CoPP)

Fast processing of verified regulatory certificates to validate global production standards.

04

Stability Studies & Shelf-Life

Rigorous stability testing across global climatic zones to secure product integrity in every market.

05

GMP Audit Support

Audit-ready records and full transparency for international buyers and external regulatory inspectors.

06

Market-Specific Compliance

Registration expertise mapped to each region's requirements across 5 global continents.

How It Works

From enquiry to international dispatch

Click any step to see what happens — a defined, friction-free commercial timeline.

1

Inquiry Intake

Share your market and product needs.

2

Dossier Sharing

CTD/eCTD dossier provided for review.

3

Registration Support

We assist with local approval filing.

4

Sample Dispatch

Product samples shipped for validation.

5

Commercial Order

Confirmed bulk order to our factory.

6

On-Time Delivery

Customs-ready dispatch to your market.

01

Inquiry Intake

You share your target market, product range and volume. We confirm feasibility and the registration route for your country within 48 hours.

Global Reach, Local Compliance

Registered across 5 continents

Hover a market to trace it on the map. Our regulatory cell clears customs and health-authority requirements market by market — so your distribution lines stay live, everywhere.

Africa
Latin America
CIS Countries
South Asia
Middle East
South-East Asia
CTD/ eCTD format
Zone IVbstability data
Zeroconsultant dependency
INDIA · HUB AFRICA LATAM CIS S. ASIA MID-EAST SE ASIA
150+ PRODUCT DOSSIERS5 CONTINENTS100% IN-HOUSEZERO CONSULTANT DEPENDENCYWHO-GMP CERTIFIED 150+ PRODUCT DOSSIERS5 CONTINENTS100% IN-HOUSEZERO CONSULTANT DEPENDENCYWHO-GMP CERTIFIED
Resources for Evaluation

Everything your team needs to assess us

The documents your regulatory and procurement teams forward internally — ready to download, no friction.

Product Dossier List

150+ products with registration-ready documentation.

Download PDF

Sample CoPP & CoA

See our certificate and analysis quality first-hand.

Download PDF

WHO-GMP & ISO Certificates

Current certifications, verifiable and dated.

Download PDF
Register & Scale Globally

Looking to register our products in your country?

Tell us your market and product range. Our regulatory team will share the dossier and map the registration path for you.

Talk to Our Regulatory Team