EUROPE & UK
Comprising seasoned professionals from the pharmaceutical industry on a global scale, our team offers vital support to ensure your success in every regulatory facet of life sciences in Europe — from development and registration to commercialization. Leveraging our expert knowledge of EU procedures, we guarantee the success of your product.
Regulatory oversight in the United Kingdom (UK) is managed by the Medicines and Healthcare products Regulatory Agency (MHRA). With a range of procedures and the implications of Brexit, navigating the UK's regulatory terrain may present challenges in securing essential market authorizations. Be confident, we are here to lead you through this intricate regulatory journey.
Services We Offer
- Regulatory intelligence & Regulatory strategy
- Expert reports in line with current regulations
- Gap analysis
- Preparation, Review, Submission & registration of dossiers
- DMF review
- Dossier Extensions
- Vigilance, safety alerts & guidance
- Medical device regulation & safety
- Marketing authorisations, variations, and licensing guidance
- Herbal and homeopathic medicines
- Query responses
- Evaluation & submission of variations
- Artwork & labelling
- Lifecycle Management – renewals & line extensions
- Market authorization transfers
- EU National, MRP, DCP and Centralised Procedures
- EU/UK contact point for non-EU/UK established MAHs
- Scientific advice
- CE marking and EU MDR Support