Our full range of regulatory services covers all stages of drug development, and encompasses manufacturing and quality, non-clinical and clinical aspects. We have experience with new and existing synthetic molecules, biologicals, as well as other novel technologies and devices. We are compliant with the requirements and guidance of the International Conference on Harmonisation (ICH) and all major regional and national regulatory agencies in Europe, North America, Japan and elsewhere.

We are experienced in using the Common Technical Document (CTD) format and are experienced in adapting documentation to this format from other dossier formats.

Project size is not an issue and we are happy to take on complete programmes or work on individual tasks. We are proud to offer a flexible and pragmatic approach to regulatory activities:

• Procedural advice (European MRP, Centralised, Decentralised, Orphan Drug, Borderline Substances etc.)
• Liaison and negotiation with Competent Authorities, EMEA, MHRA etc.
• Scientific advice, hearings etc
• Liaison with Notified Bodies for Medical Devices
• Authoring and review of IMPDs and IBs
• Preparation and submission of CTAs and INDs
• Application dossier preparation
• Overall Summaries and Expert Comments