Specialist Advisory Services
Pharmaceutical Strategy & Portfolio Advisory
Board-level strategic direction for products and portfolios — positioning, licensing routes, indication and lifecycle planning, and market-entry readiness. We turn complex options into one clear, commercially viable plan.
Medical Affairs & Scientific Advisory
Senior medical affairs and scientific advisory — evidence review and literature appraisal, medical strategy, scientific positioning, medical writing and HCP-facing materials — aligning your clinical credibility with regulatory, medical and commercial objectives.
Regulatory Affairs & Lifecycle Management
End-to-end regulatory affairs across UK, EU, Gulf and international pathways — submissions, variations, renewals, SmPC/PIL and product information — keeping your portfolio compliant, current and commercially relevant. Post-Brexit UK licensing a speciality.
Product Development, CMC & Technical Dossier Support
Technical and CMC advisory from formulation to filing — quality documentation, manufacturing considerations, stability, Module 3 readiness and dossier planning — connecting product-design decisions to regulatory and launch requirements.
Medical Information & Scientific Communications
A compliant medical information service — accurate, balanced responses to HCP, patient and carer enquiries, standard response documents, enquiry triage and PV interfacing — protecting both your brand and your patients.
Pharmacovigilance, RMPs & Safety Governance
Pharmacovigilance built to inspection-ready standard — PSMF, RMPs, ICSR and safety-escalation pathways, SOPs, training, CAPA and audit readiness — aligned to GVP and MHRA expectations.
Compliance, ABPI/PMCPA & Healthcare Governance
ABPI/PMCPA compliance and Final Medical Signatory support — MLR review, certification and examination of promotional and non-promotional materials, and SOP frameworks — keeping your communications compliant and defensible.
Market Access, Category Switch & Commercial Strategy
UK market access and commercial strategy — pricing and reimbursement, NHS listing, dm+d, Drug Tariff, formulary access and category switch — engineered for launch success and sustainable uptake.
Strategic Partnerships, Ventures & International Expansion
Bi-directional UK ↔ Gulf expansion and partnership advisory — market entry, local-partner strategy and investor-facing support across the UK, Saudi Arabia and the wider Gulf — from concept to commercial growth.