Our Approach

Our consultants have expertise across EU and US regulations and have years of experience interacting with competent authorities in these regions.

We pride ourselves on being up to date on the latest regulatory matters: MDR or IVDR in the area of medical devices OR IVDs, Brexit impact and relationships between the UK and EMA, GMP Annex 1…

Regulatory Affairs
in MedTech

• UK Responsible Person Services (UKRP)
• CE Technical Documentation & Design Dossiers
MDR & IVDR technical file remediation and compilation (EU 2017/745) & (EU 2017/746)
UKCA Marking
CE Marking
Clinical Evaluation Report (CER) Writing
Risk Management
• Performance Evaluation Report (PER) writing
• Post-Market Clinical Follow-up protocol (PMCF)
• Periodic Safety Updated Report (PSUR)
• FDA 510(k)s/ De Novo Submissions

Regulatory Affairs
in Biotech

• Marketing Authorisation Transfers
• EU Clinical Trial Regulation (CTR)
New Marketing Authorisation Application
• Variation Application
• Renewal application (national, MRP, DCP)
• Artwork & Production Management
• BLA Submissions
• Non-clinical IND authoring
IDMP Implementation

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