Our services

Your one-stop solution for regulatory success in pharma, biotech and medtech.  

We help you to navigate the complexities of global regulatory frameworks with confidence. Out expert support spans every stage of the product lifecycle – from early development to marketing authorisation – ensuring compliance clarity and speed.  

Regulatory Strategy Development  

Customised roadmaps to support your clinical and commercial goals, aligned with global agency expectations.  

Small and Medium Enterprise (SME) Incentives  

Support for securing Small and Medium Enterprise (SME) status with the EMA – enabling access to feed reductions and regulatory incentives.  

Orphan Drug Designation (ODD)  

Strategic planning and full support for EU/US ODD applications, including eligibility assessment justification writing.   

PRIME: Priority Medicines for Breakthrough Therapies  

Expert navigation of accelerated programmes such as EMA PRIME, MHRA ILAP, and FDA Fast Track – from eligibility through to agency engagement.  

Scientific Advice Procedures  

Comprehensive support for Scientific Advice with the EMA, MHRA and national agencies – including briefing document preparation, meeting support and follow-up strategy.  

Paediatric Investigation Plans  

Drafting, submission and negotiation of Paediatric Investigation Plans, including waiver/deferral strategies across Europe and the UK.  

Quality and CMC Expertise  

End-to-end Chemistry Manufacturing and Controls (CMC) support – from development-phase planning to Module 3 preparation and post-approval change management. 

Dossier Development and Submission Management  

Preparation, review and submission of robust regulatory dossiers (eCTD/NeeS), ensuring accuracy, alignment and agency-readiness.  

Regulatory On Call

• Answers to your ad hoc regulatory questions at the end of the phone or by email
• Quick turnaround regulatory advice & consultancy as and when required
• Managed via a monthly retainer fee