Regulatory, Certification & Registration Advisory Service

This consultancy service supports research institutions, academia, SMEs, spin-offs and startups developing medicinal products, medical devices, IVDs and combination products. It helps navigate the manufacturing (CMC- Chemical, Manufacturing & Controls), regulatory and clinical landscapes from early development to registration in EU, US, UK, Switzerland and Health Canada. 

Key components include: 
a) Regulatory classification of the product (e.g., drug vs. device/IVD); 
b) Regulatory roadmap outlining development steps, documentation, and timelines up to clinical trials or CE marking; 
c) Support with regulatory authority engagement (e.g., FDA/EMA/EU Health Authorities interactions, device consultations, innovation offices); 
d) Expert reports on regulatory strategies, requirements, and development plans; 
e) Guidance on procedures, such as Orphan Drug Designation or SME status; 
f) Training and coaching, through workshops or individual sessions. 

The service includes strategic advice to ensure regulatory alignment, optimise planning, and reduce risks. It is available at any development stage, with scope and timeline adjusted to project complexity. Deliverables include tailored roadmaps, strategic recommendations, and if applicable, summaries of agency interactions to support regulatory compliance and market entry.