All Services — Context International
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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02
Regulatory Affairs Operations
Submission management, dossier preparation, and lifecycle administration across GCC and EU markets
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03
Quality Systems Administration
GxP-compliant documentation, CAPA management, and quality record administration for regulated environments
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04
Clinical Data Operations
Trial Master File management, CRF data entry, and clinical data coordination for sponsors and CROs
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05
Medical Information & Literature
Systematic literature monitoring, medical information enquiry management, and standard response documentation
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06
Regulatory Project Management
Senior coordination, timeline management, and cross-functional oversight for complex multi-market regulatory programmes
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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.

Ready to discuss your operational requirements?

Whether you need an integrated cross-functional team or support in a single compliance discipline, we can structure an engagement around your exact needs.

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