Regulatory Affairs Operations — Context International

Service 02 / Regulatory Affairs

Regulatory Affairs Operations

Getting a medicine from dossier to shelf in GCC markets requires navigating six distinct regulatory authorities, varied data requirements, and compressed timelines — simultaneously. We manage the operational complexity so your regulatory strategy can execute without bottlenecks.

GCC authorities — distinct requirements

CTD

Common technical document — our native format

MAH

Marketing authorisation holder support

Market coverage

Six authorities. One integrated operation.

Each GCC market has distinct dossier requirements, timelines, and authority preferences. Understanding the nuance across all six is what separates compliant registrations from repeated query cycles.

UAE

MOHAP / DHA / HAAD

Saudi Arabia

SFDA

Kuwait

MOH Kuwait

Qatar

MOPH Qatar

Bahrain

NHRA

Oman

MOH Oman

CTD Structure

The Common Technical Document — our native format

Module 1

Administrative

Application forms
Regional product information
Expert reports
GCC cover letters

Module 2

Summaries

Quality Overall Summary
Nonclinical Overview
Clinical Overview
Summary tabulations

Module 3

Quality

Drug substance data
Drug product data
Stability studies
Batch analysis

Module 4

Nonclinical

Pharmacology reports
Toxicology studies
ADME data
Safety pharmacology

Module 5

Clinical

Clinical study reports
Literature references
Synopses
Datasets

What we deliver

Regulatory operations across the product lifecycle

①

New Product Registration

End-to-end dossier preparation and submission management for new marketing authorisation applications. CTD compilation, Module 1 region-specific adaptation, authority query response coordination, and approval tracking across GCC authorities.

②

Variation Management

Post-approval variation submissions — Type I, Type II, administrative, and safety variations. Change management tracking, variation classification guidance, and simultaneous multi-market variation submission coordination.

③

Renewals & Maintenance

Marketing authorisation renewal submissions, licence maintenance, and ongoing post-approval commitments. Expiry tracking systems, renewal dossier compilation, and coordination with manufacturing sites for updated data.

④

Authority Query Management

Rapid response drafting for regulatory authority queries. Structured query analysis, response compilation from clinical and quality teams, and authority correspondence management to prevent review clock delays.

⑤

Labelling & SmPC

Product information document management — SmPC, PIL, and labelling text preparation and maintenance. Regional adaptation of EU or US reference product information to GCC authority requirements.

⑥

Regulatory Tracking

Portfolio-wide regulatory tracking and reporting. Approval date monitoring, variation status dashboards, renewal calendars, and regulatory intelligence on authority guideline updates affecting your product portfolio.

Typical registration timeline

GCC registration — from preparation to approval

Dossier Gap Analysis

Existing data assessed against authority requirements. Gaps identified and prioritised.

CTD Compilation

Module preparation, regional adaptation, and internal review cycles completed.

Submission

Dossier submitted to target GCC authorities. Acknowledgement and clock start confirmed.

Query Response

Authority questions addressed. Supplementary data compiled and submitted.

M12

Approval

Marketing authorisation issued. Licence management and post-approval obligations commence.

Platforms & tools

Systems our teams work in — from day one

Veeva Vault RIM LORENZ docuBridge SFDA GHAD Portal MOHAP eServices Microsoft SharePoint CTD Publisher eCTD Viewer Regulatory Tracking Systems

Our location is our advantage

Dubai-based regulatory operations — inside the GCC market, with the authority relationships and time zones that matter.

Ready to advance your GCC registration programme?

Whether you are entering the GCC for the first time or managing a portfolio of authorisations across multiple markets — we build the operational backbone your regulatory strategy requires.

Start a conversation All services