Context International — Life Sciences Regulatory Operations
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
About Us

Building the operational foundation for compliance.

About Context International

Technology-enabled teams for life sciences compliance.

  • Pharmacovigilance & Drug Safety Operations
  • Regulatory Affairs & Submissions Management
  • Quality Systems Administration — GxP, GMP, GCP
  • Clinical Data & Trial Master File Operations
  • Medical Information & Literature Monitoring
  • GCC Multi-Market Regulatory Coordination
  • Regulatory Project & Programme Management

Context International is a Dubai-based regulatory operations partner for pharmaceutical, biotech, and medical device companies. We build dedicated teams that function as a seamless extension of your internal compliance function — trained to your SOPs, aligned to your timelines, and accountable to your quality standards.

Our professionals hold relevant degrees in pharmacy, life sciences, and biomedical sciences, with hands-on operational experience in the platforms the industry runs on: Oracle Argus, Veeva Vault, MedDRA, Medidata Rave, and the eTMF systems your regulatory team depends on daily.

We serve companies navigating the complexity of GCC multi-market registration — MOHAP, SFDA, DHA, Kuwait MOPH — alongside those with European post-marketing obligations under EMA and ICH frameworks. One dedicated operations partner, capable across both markets.

Unlike large CROs where small accounts receive limited attention, or boutique consultancies billing at Scandinavian day rates, we offer the responsiveness of a fully dedicated team at an operational cost that reflects our regional footprint — without compromise on quality, qualifications, or regulatory rigour.

Why Context International

What makes us different.

◈
Dedicated, not shared

Your team works exclusively on your account. No resource rotation across competing clients, no account managers juggling priorities. The same qualified professionals show up for your programme every day — building institutional knowledge of your systems, your products, and your regulatory landscape that compounds over the engagement.

◈
Qualified from the first day

Every professional we place holds a relevant degree — B.Pharm, M.Pharm, BSc or MSc in life sciences or biomedical sciences — and is trained and experienced in the specific platforms your operations run on. There is no ramp-up period where you are paying for someone to learn the basics. They arrive ready to work.

◈
GCC and international standards, both

Our teams are trained to operate across both GCC health authority requirements — MOHAP, SFDA, DHA, Kuwait MOPH — and international EMA, ICH, and GCP frameworks. For companies with simultaneous GCC and European regulatory obligations, we provide a single operations partner across both, removing the coordination overhead of managing multiple providers.

◈
Operationally priced

Large CROs price at enterprise rates designed for global pharma programmes. Nordic and European regulatory boutiques bill at Scandinavian salary levels that price out smaller companies. We offer dedicated, qualified regulatory operations capacity at a cost structure that reflects our Dubai footprint — making the economics work for companies at every stage of commercial development in the GCC.

How we work

A dedicated team. Your processes. Your standards.

01
Scoping

We map your regulatory footprint, submission volumes, and capacity gaps across each market you operate in. No generic proposals — every engagement is designed around your actual requirements, timelines, and budget parameters.

02
Team build

We identify and assemble a dedicated team of qualified professionals matched precisely to your therapeutic areas, regulatory jurisdictions, and technical environment — including the specific platforms and databases your operations rely on.

03
Onboarding

Your team is trained to your SOPs, access-provisioned to your systems, and aligned to your quality standards before any operational work begins. We integrate into your processes — not the other way around. Typical onboarding takes one to two weeks.

04
Delivery

Consistent, accountable operations with a single point of contact, documented escalation paths, and regular performance reporting. Fixed monthly engagements — no billable hour ambiguity, no rotating staff, no surprises.

Our Services

Specialist operations across every dimension of regulatory compliance.

Each engagement is structured around a dedicated team, qualified for your specific markets and platforms. We do not rotate resources across clients. The same professionals show up for your programme, every day — building depth in your operations.

01
Pharmacovigilance Operations
End-to-end drug safety case processing, MedDRA coding, and safety database management — ICH E2B and GVP-compliant
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What we deliver

Pharmacovigilance operations are the backbone of post-marketing compliance. Our certified PV professionals manage the full ICSR lifecycle — from case intake and triage through coding, narrative writing, submission, and follow-up — with accuracy and within your required reporting timelines.

We work to ICH E2B(R3) standards and EMA GVP Module VI requirements, with full awareness of local MOHAP and GCC pharmacovigilance guidelines for companies with GCC marketing authorisations.

  • Individual Case Safety Report (ICSR) intake, triage, and processing
  • MedDRA coding to current version — PT, HLT, SOC hierarchy
  • Medical narrative writing and case assessment
  • Expedited and periodic safety report submission
  • PSUR and DSUR aggregate report preparation support
  • Signal detection and literature monitoring programmes
  • MOHAP, SFDA, and GCC local PV authority reporting
  • Safety database reconciliation and data quality management

Platforms & tools

Oracle Argus Safety ARISg MedDRA Browser E2B(R3) Gateway Veeva Safety PubMed / Embase

Qualifications

B.Pharm / M.Pharm PharmD BSc / MSc Life Sciences CPVC certified DIA Drug Safety
Overwhelmed by ICSR volume? Unable to meet 15-day expedited reporting windows? We can scale a dedicated PV team to your case load within weeks.
Discuss your requirements
02
Regulatory Affairs Operations
Submission management, dossier preparation, and lifecycle administration across GCC and EU markets
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What we deliver

Regulatory affairs operations are the machinery behind every product on the market. Our teams manage the documentation-intensive workload that keeps marketing authorisations current — from initial dossier compilation through variations, renewals, and labelling updates across multiple jurisdictions simultaneously.

For companies with GCC commercial operations, we coordinate submissions across MOHAP, SFDA, DHA, Kuwait MOPH, and Bahrain NHRA — managing jurisdiction-specific dossier requirements and procedural differences as a single point of accountability.

  • CTD / eCTD dossier compilation and submission management
  • Type IA, IB, and II variation preparation and tracking
  • Marketing authorisation renewal management
  • Labelling, PIL, and artwork coordination and version control
  • Submission tracking, timeline management, and HA correspondence
  • Veeva Vault RIM content management and workflow administration
  • MOHAP, SFDA, DHA, and GCC multi-market submission coordination
  • Regulatory intelligence monitoring — guidance updates, new requirements

Platforms & tools

Veeva Vault RIM eCTD Publishing Lorenz docuBridge MOHAP eServices SFDA Portal EMA SPOR/XEVMPD

Qualifications

B.Pharm / M.Pharm BSc Life Sciences RAPS RAC TOPRA qualified
Managing GCC multi-market registration with a small internal team? We provide the operational depth to run parallel submissions without your regulatory director becoming a bottleneck.
Discuss your requirements
03
Quality Systems Administration
GxP-compliant documentation, CAPA management, and quality record administration for regulated environments
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What we deliver

Quality systems administration is the scaffolding that makes regulated operations inspection-ready. Our QA operations professionals manage the documentation lifecycle — SOPs, deviations, CAPAs, change controls, and training records — ensuring your quality management system functions as a living, auditable framework rather than a paper archive.

We work across GMP, GCP, and GLP environments, with full fluency in eQMS platforms and document control principles that will withstand regulatory inspection.

  • SOP writing, review, approval, and version control management
  • Deviation and non-conformance documentation and root cause analysis support
  • CAPA initiation, tracking, effectiveness verification, and closure
  • Change control request processing and documentation
  • Training record administration and compliance tracking
  • Audit trail maintenance and inspection-readiness documentation
  • eQMS platform administration — content management, workflows, permissions
  • Periodic quality review documentation and reporting support

Platforms & tools

Veeva Vault QMS MasterControl TrackWise Documentum SharePoint QMS

Qualifications

B.Pharm / BSc Sciences GxP training certified ISO 9001 awareness ASQ CQA
Facing an upcoming inspection or audit? Quality documentation backlogs are a common pressure point. A dedicated QA administrator can clear the backlog and keep systems current.
Discuss your requirements
04
Clinical Data Operations
Trial Master File management, CRF data entry, and clinical data coordination for sponsors and CROs
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What we deliver

Clinical data operations support the documentation backbone of clinical trials — ensuring that the Trial Master File is complete, current, and inspection-ready from study startup through close-out, and that data entered into EDC systems is accurate, timely, and reconciled.

Our clinical operations professionals are trained to ICH GCP E6(R2) standards and experienced in the eTMF and EDC platforms your clinical operations team relies on. We support GCC-based clinical sites and studies as well as international programmes coordinating from Dubai.

  • eTMF setup, structure maintenance, and ongoing document filing
  • TMF completeness tracking and inspection-readiness assessment
  • CRF data entry, query resolution, and data reconciliation
  • EDC platform user management and data quality monitoring
  • Study startup documentation — site files, essential documents
  • Investigator Site File (ISF) preparation and maintenance support
  • Clinical operations coordination — meeting minutes, action tracking
  • GCP compliance documentation and training record management

Platforms & tools

Veeva Vault eTMF Medidata Rave Oracle InForm REDCap Viedoc Florence eBinders

Qualifications

BSc Biomedical Sciences BSc Life Sciences ICH GCP certified ACRP / SCDM
TMF completeness gaps are one of the most common findings in FDA and EMA inspections. A dedicated eTMF administrator ensures your trial documentation is always audit-ready.
Discuss your requirements
05
Medical Information & Literature
Systematic literature monitoring, medical information enquiry management, and standard response documentation
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What we deliver

Medical information operations sit at the intersection of pharmacovigilance and scientific communication. Our medical information professionals manage enquiry handling workflows, maintain standard response document libraries, and run the systematic literature monitoring programmes required for signal detection and aggregate safety reporting.

For GCC-based MAHs, we support local medical information obligations and can coordinate multi-language enquiry management for the region's diverse healthcare professional base.

  • HCP and patient medical information enquiry documentation and response
  • Standard response document (SRD) library maintenance and version control
  • Systematic literature monitoring — PubMed, Embase, Ovid, Cochrane
  • Literature search strategy design and execution
  • Relevant publication identification and triage for safety review
  • Unsolicited adverse event identification within medical information contacts
  • Medical writing coordination — labels, summaries, clinical overviews
  • Medical affairs documentation support

Platforms & tools

PubMed / MEDLINE Embase Ovid SP Cochrane Library EndNote Covidence

Qualifications

B.Pharm / PharmD BSc Life Sciences Nursing background AMWA trained
Literature monitoring backlogs create signal detection gaps. A dedicated medical information professional ensures your SRD library stays current and your monitoring obligations are met continuously.
Discuss your requirements
06
Regulatory Project Management
Senior coordination, timeline management, and cross-functional oversight for complex multi-market regulatory programmes
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What we deliver

Regulatory project management provides the coordination layer that keeps complex, multi-market programmes on track. Our project managers bring structure to the interface between regulatory operations, clinical teams, manufacturing, and health authorities — translating regulatory requirements into deliverable timelines and managing the interdependencies that determine submission success.

We are particularly well-positioned to support GCC market entry programmes, where navigating parallel submissions to multiple health authorities with differing procedural requirements and timelines demands experienced, dedicated coordination.

  • Multi-market submission timeline development and management
  • Regulatory milestone tracking and risk identification
  • Health authority query management and response coordination
  • Cross-functional regulatory meeting facilitation and minutes
  • Regulatory intelligence tracking — relevant guidance and policy changes
  • Submission readiness assessment and gap analysis
  • Regulatory strategy execution support and progress reporting
  • Outsourcing vendor management and performance oversight

Platforms & tools

Veeva Vault MS Project Smartsheet Confluence JIRA (regulated)

Qualifications

M.Pharm / MSc Life Sciences RAPS RAC PMP / PRINCE2 5–10 yrs regulatory experience
Entering the GCC market with multiple products and no dedicated regulatory project manager? We provide senior programme coordination without the full-time headcount commitment.
Discuss your requirements
Engagement models

Three ways to work with us.

Every engagement is different. We structure around your requirements — whether you need ongoing embedded support, a project-specific team, or a specialist placed within your existing function.

Insights

Regulatory intelligence for life sciences teams.

Practical perspectives on regulatory operations, pharmacovigilance practice, and GCC market dynamics — written for the professionals managing these programmes day to day.

Pharmacovigilance February 2026
Managing ICSR Backlogs: Why Small Pharma Companies Lose Control of Their Safety Databases — and How to Recover
For small and mid-size pharmaceutical companies, Individual Case Safety Report backlogs are one of the most quietly dangerous compliance risks in the post-marketing phase. Unlike a failed regulatory submission — which generates immediate, visible consequences — a growing ICSR backlog can accumulate for months before it becomes a formal inspection finding.
Read article
GCC Regulatory January 2026
Navigating Multi-Market Registration in the GCC: Why Parallel Submissions Require a Different Operational Model
Companies entering the GCC pharmaceutical market often underestimate the operational demands of running simultaneous submissions across MOHAP, SFDA, and other health authorities. The technical regulatory requirements are well-documented. The operational infrastructure required to execute them efficiently is less discussed.
Read article
Operations December 2025
The Trial Master File at Inspection: What Regulators Look for and What Operations Teams Miss
The Trial Master File is the documentary evidence that a clinical trial was conducted according to GCP. When inspectors arrive, they assess the TMF for completeness, contemporaneity, and accuracy. Most deficiencies are operational — and preventable.
Read article

Get in touch

Let's discuss your regulatory operations.

Contact Information
Headquarters
Dubai, United Arab Emirates
Email
info@contextinternational.com
Response time
Within 24 hours
Initial conversation
No obligation. We begin by listening.
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Frequently asked

Questions clients ask us.

How quickly can you have a team operational?
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For standard engagements, we can have a qualified team identified and entering onboarding within two to four weeks of scope agreement. The onboarding period — during which your team is trained to your SOPs, access-provisioned to your systems, and quality-checked on outputs — typically runs one to two additional weeks depending on the complexity of your environment. For urgent requirements, particularly around pharmacovigilance coverage gaps, we can discuss expedited arrangements.
Do your teams work in our systems, or do you require us to use yours?
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We work exclusively in your systems. Whether you run Oracle Argus, Veeva Vault, Medidata Rave, a proprietary safety database, or a locally hosted document management platform — your team is trained and access-provisioned to operate directly within your existing environment. We do not require you to migrate to any platform we own, licence, or prefer. Our value is operational, not technological.
What qualifications do your pharmacovigilance professionals hold?
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Our pharmacovigilance professionals hold relevant life sciences degrees — B.Pharm, M.Pharm, PharmD, or BSc / MSc in biology, biomedical sciences, or a related discipline — and have hands-on operational experience in MedDRA coding, ICSR case processing, and safety database management. Most have two or more years of direct PV operations experience at CROs or pharmaceutical companies. Many hold additional certifications including CPVC, DIA Drug Safety credentials, or RAPS RAC designations. We match qualification profiles to your specific requirements and provide full CVs for your review before any team member begins work.
We are a small company with limited budget. Is there a minimum engagement size?
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No minimum. We work with companies of all sizes — from single-product specialty distributors managing GCC submissions through to mid-size pharmaceutical companies running multi-market post-marketing programmes. If your workload requires one dedicated professional or a full team of eight, we structure the engagement accordingly. Some of our most productive relationships are with small GCC commercial operations that have a single regulatory manager who cannot manage the full documentation workload alone.
How are engagements priced?
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We operate on fixed monthly retainers, priced per professional and engagement scope. This gives you entirely predictable cost and consistent delivery — without the ambiguity of billable hours, variable monthly invoices, or scope creep discussions. Pricing is agreed at the start of the engagement based on the specific roles, qualification levels, workload parameters, and markets involved. We provide a full written scope and service agreement before any work begins.
Can you handle MOHAP and SFDA submissions at the same time?
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Yes. Our regulatory teams are specifically trained in GCC health authority requirements and are experienced in managing concurrent submissions across MOHAP (UAE), SFDA (Saudi Arabia), DHA, Kuwait MOPH, Bahrain NHRA, and other regional regulators simultaneously. We understand the dossier variations, procedural differences, and timeline requirements between jurisdictions — and can act as a single point of accountability for a full GCC market entry programme, coordinating parallel submissions without requiring your internal team to manage each authority separately.