• Appeals and referrals
• Assessment of scientific data
• CE marking of medical devices
• Centralised, decentralised, mutual recognition and national procedures
• Clinical development
• Clinical trial authorisations
• Compiling/writing of dossiers
• Classification of drugs, medical devices, cosmetics and foods
• eCTD compilation and publishing
• GCP and GMP audits
• Readability / user testing
• Liaison with regulatory authorities
• Licensing
• Medical writing
• Orphan medicinal product designation
• Pharmaceutical development
• Pharmacovigilance
• Pre-clinical development
• Pricing and reimbursement
• Promotional material review
• Renewals
• Regulatory intelligence
• Scientific advice applications
• Strategic regulatory planning
• Translations
• Variations
• Writing of summaries and expert reports

European & National Expertise in Regulatory Affairs