» Regulatory Affairs
- MEDICINAL PRODUCTS
- Preparation, submission, follow-up and maintenance of marketing authorisation applications, variations, renewals, export declarations, free sales certificates
- Preparation, submission, follow-up of clinical trial applications (CTA), amendments, notifications, declarations according to Vol 10
- Data evaluation and strategic advice
- Expert report/summary writing (analytical, toxicological, clinical)
- Local interface between the client and the local competent authorities
- Out-licensing service
- RAW MATERIALS
- MEDICAL DEVICES
- NUTRIENTS
- COSMETICS
» Quality Services
- QUALITY ASSURANCE
- Best practice manuals
- Audits
- QUALIFIED PERSON
- EU QP Batch Release – import third countries
- Local QP – intra-Community distribution
- VIGILANCE
- QP Pharmacovigilance according to Vol 9A (24/7 call center service for health professionals, sales forces, customers, patients)
- QP Materiovigilance
- PUBLICITY & MEDICAL INFORMATION
- QP publicity
- Artwork review/approval (SmPC, PL, labelling)
- Promotional material review/approval
- Training support sales force
» Scientific Translations
- Leaflets, labels, SmPC
- Scientific texts, expert reports, presentation folders