Market Access, Regulatory and Clinical Trial Consultants
Supporting Pharma and Biotechs with Regulatory Affairs, HEOR and Market Access – delivered by a specialist network of pharmaceutical consultants.
Our Services
We work alongside your team to provide clear, focused support across Regulatory strategy and support, HEOR and Market Access – helping you reduce delays and move forward with confidence.
Regulatory Consulting
Regulatory strategy consulting support from early development through to authorisation.
As pharmaceutical regulatory consultants UK, we help you navigate EU, UK and Swiss regulatory requirements with confidence.
- CTA and MAA preparation and submission
- Scientific advice and regulatory strategy
- Orphan designation and paediatric plans (PIP)
- EMA and MHRA pathway alignment (PRIME, ILAP)
Market Access
Help you quantify and communicate the clinical and economic value of healthcare interventions to payers, regulators, and clinicians (HEOR). Prepare for product launch and reimbursement across European markets (HTA), provided by one of the leading pharmaceutical consulting companies supporting biotech growth.
- Health Economics and Outcomes Research (HEOR)
- Health Technology Assessment (HTA) alignment
- Launch readiness and commercial support
- Market access strategy and planning
- European legal entity setup and expansion
Medical Writing
End-to-end medical writing throughout development and after authorisation, delivered by experienced medical writing specialists.
- Protocol, IB and CSRs
- DSUR (Development Safety Update Report)
- PBRER (Periodic Benefit-Risk Evaluation Report)
- RMP (Risk Management Plan)
Our Core Expertise
- Regulatory strategy and scientific advice – Clear guidance to support decision-making at every stage of development and answer key questions such as what is regulatory affairs in pharma and how it applies to your programme.
- Marketing authorisation applications (MAA) – Preparation and submission aligned with EMA, MHRA and EU requirements.
- Orphan designation and paediatric plans – Strategic support for orphan status and PIP development, including PDCO interaction.
- Clinical trial applications (CTA) – Efficient CTA strategy and submissions across the EU, UK, Switzerland and beyond, supported by experienced clinical trial consultants.
- European expansion support – Establishing legal entities, headquarters and operational presence in Europe.
Speak To a Regulatory Expert
If you’re planning a CTA, preparing for MAA, or need support navigating EU and UK requirements, we can help. Get in touch with our team of pharmaceutical strategy consultants today and see how we can support your growing biotech.
Contact Us
Recent Articles
EU HTAR: Updated Q&As on Joint Clinical Assessments – Key Insights and Sponsor Implications (May 2026)
On 18 May 2026, the Member State Coordination Group on Health Technology Assessment (HTACG) released significant updates to the Questions and Answers documents on Joint…
IHSI’s role and HTA in the EU
Here is the clarification of IHSI’s role, its relationship to the EU institutions, and your obligations as a company. 1. What is IHSI? (The Legal…
News and Updates
EMA PIP Reference numbers
Historically (and still referenced in many older documents and systems like EudraCT), the final EMA decision on a Paediatric Investigation Plan (PIP) was commonly identified…