Every service Glaslyn Regulatory offers is designed for one specific client: an Indian pharmaceutical company that wants to sell medicines in the United Kingdom legally, efficiently, and without the costly surprises that come from navigating MHRA requirements without specialist guidance.
We work with a small number of clients at any one time to ensure the quality of advice is never compromised. If you are considering UK market entry, we recommend beginning with an MHRA Gap Analysis—the fastest and most cost-effective way to understand exactly where you stand.
Before you invest in a UK submission, know exactly what is missing. Our MHRA Gap Analysis reviews your existing regulatory documentation against current MHRA requirements. We produce a comprehensive written report identifying every gap, prioritising them by urgency and commercial impact, and providing a clear remediation roadmap.
What you receive: A detailed written report covering every module of the CTD dossier against MHRA standards, a prioritised list of gaps with recommended actions, a realistic timeline and cost estimate for remediation, and a 60-minute debrief call to walk through the findings.
Investment: From £2,500 — fixed price, delivered within 10 working days.
UK Regulatory Strategy and Market Entry Planning
Getting to UK marketing authorisation is not simply a matter of preparing a dossier. It requires a strategic plan that accounts for your product type, your manufacturing site, your existing regulatory approvals, your target timeline, and your commercial objectives.
We develop a comprehensive UK regulatory strategy for your product or portfolio — covering submission route selection, pre-submission meeting planning with MHRA, timeline management, fee planning, and risk mitigation. You receive a document that functions as an operational roadmap for your UK regulatory programme.
Investment: From £5,000 — scoped individually based on product complexity and portfolio size.
CTD Dossier Preparation and Review
The Common Technical Document submitted to the MHRA must meet UK-specific requirements that differ in important ways from both the EU CTD and the Indian CDSCO dossier format. Module 1 in particular is entirely UK-specific.
We prepare or comprehensively review your CTD dossier to MHRA standards — module by module, section by section. We identify deficiencies before MHRA does and ensure your submission is technically sound before the clock starts.
Investment: From £8,000 — scoped by product type, indication, and existing documentation quality.
UK Pharmacovigilance System Setup
Any company holding or seeking a UK marketing authorisation must have a fully compliant UK pharmacovigilance system in place. This includes a Pharmacovigilance System Master File (PSMF), a Qualified Person for Pharmacovigilance (QPPV) arrangement, a PSUR submission schedule, and robust ADR reporting processes.
We establish your UK pharmacovigilance system from the ground up — or review and remediate your existing system. We provide or arrange QPPV services, draft your PSMF, configure your reporting calendar, and ensure you are inspection-ready from the moment your product is approved.
Investment: From £3,000 for initial setup — ongoing support available via monthly retainer.
Monthly Regulatory Retainer
UK regulatory compliance does not end at approval. Variations, renewals, PSURs, MHRA correspondence, labelling updates, and ongoing pharmacovigilance obligations require consistent expert attention. Our monthly retainer provides Indian pharmaceutical companies with a dedicated UK regulatory resource — without the cost of a full-time UK regulatory affairs hire.
Retainer clients receive priority response times, monthly regulatory intelligence briefings, and direct access to Mustafa Laxmidhar for strategic queries.
Investment: From £1,500 per month — scope and fee agreed based on portfolio size and activity level.
Not sure which service is right for you? Most Indian pharmaceutical companies entering the UK market begin with an MHRA Gap Analysis. Book a free 30-minute discovery call to discuss your situation. There is no obligation and no sales pressure.