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.
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.
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.
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.
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.
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.
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.
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.
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.