Regulatory & Pharmacovigilance Operations

Precision operations
for life sciences
compliance.

Context International builds dedicated regulatory affairs, pharmacovigilance, and quality operations teams for pharmaceutical and biotech companies across the GCC and Europe. Qualified professionals. Your systems. Your standards.

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Operational Scope

Scale and standards.

40+
Years of combined regulatory and pharmacovigilance experience across our operational teams
6+
GCC health authority jurisdictions covered — MOHAP, SFDA, DHA, Kuwait, Bahrain, Oman
ICH
All work delivered to international standards — E2B, GVP, GCP, GMP, and CTD dossier frameworks
24h
Standard turnaround commitment for routine regulatory and pharmacovigilance deliverables
Regulatory frameworks trained & supported
ICH E2B(R3) EMA GVP GxP MOHAP CTD/eCTD ISO 9001
Pharmacovigilance Operations◆ Regulatory Affairs◆ Quality Systems◆ Clinical Data Operations◆ GCC Submissions◆ MedDRA Coding◆ Oracle Argus◆ Veeva Vault◆ eTMF Management◆ PSUR / DSUR Support◆ ICSR Case Processing◆ Medical Information◆ Pharmacovigilance Operations◆ Regulatory Affairs◆ Quality Systems◆ Clinical Data Operations◆ GCC Submissions◆ MedDRA Coding◆ Oracle Argus◆ Veeva Vault◆ eTMF Management◆ PSUR / DSUR Support◆ ICSR Case Processing◆ Medical Information◆
Standards & frameworks
ICH E2B(R3) compliant
EMA GVP Module VI
MOHAP PV guidelines
ICH GCP E6(R2)
CTD / eCTD standards
ISO 9001 quality management
GxP documentation principles
SFDA regulatory requirements
Therapy areas
Oncology Rare Disease Cardiovascular Immunology CNS Infectious Disease Endocrinology Dermatology Medical Devices
Our perspective
Regulatory compliance is not a back-office function. It is the operational foundation on which every commercial decision in life sciences depends.

The companies that treat regulatory operations as a strategic capability — not an administrative overhead — consistently outperform those that do not. They register faster. They respond to health authority queries with greater accuracy. They approach inspections from a position of readiness rather than remediation. We build the operations layer that makes that possible.

Who we work with

The companies that come to us.

01
GCC commercial operations
A European pharmaceutical company with a lean Dubai office managing GCC registration across five markets simultaneously.
Internal regulatory resource is stretched across MOHAP, SFDA, and DHA submissions concurrently. Needs a dedicated operations team to manage the documentation workload while the in-house regulatory director focuses on health authority relationships and strategy.
02
Specialty biopharma
A specialty distributor licensing innovative medicines across the MENA region — not a manufacturer, but with full post-marketing PV and regulatory obligations.
Managing adverse event reporting, pharmacovigilance system maintenance, and regulatory renewals for a growing product portfolio without the infrastructure of a large pharma company. Requires a partner who can operate as a functional extension of their regulatory team.
03
Nordic / Scandinavian biotech
A Scandinavian biotech company in the post-approval phase, with European marketing authorisations and a product entering GCC markets for the first time.
Needs the dual capability of EMA-standard pharmacovigilance operations and GCC regulatory submissions expertise — managed by a single operations partner without the cost structure of a Nordic-based regulatory boutique.
The team handled our MOHAP variation filings with a level of attention and consistency we had not experienced from previous outsourcing arrangements. Every timeline was met. Every document was right first time.
Head of Regulatory Affairs
Mid-size European pharmaceutical company, GCC commercial operations
We needed pharmacovigilance case processing support at short notice. Context International had a qualified team fully operational in our Oracle Argus environment within two weeks. No ramp-up friction.
Drug Safety Manager
Specialty biopharma company, Dubai Science Park
Their regulatory submissions team understood our CTD dossier structure from the first briefing. We did not spend weeks explaining our internal processes — they came prepared, and it showed.
VP Regulatory Operations
Nordic biotech company, post-marketing lifecycle phase