For all your European regulatory requirements including:
If there are any additional services which would be of interest please do not hesitate to contact us using the form provided.
- Training programmes in all aspects of Regulatory Affairs for new or experienced staff
- Strategic advice, particularly for Generic products
- Preparation of regulatory dossiers for European markets
- Management of National, Mutual Recognition (MRP), Decentralised (DCP) and Centralised licensing
- Preparation and signature of Quality Overall Summaries, Nonclinical and Clinical Overviews and Summaries
- Formatting or reformatting of dossiers into CTD, NeeS and eCTD format
- Licence variations & renewals
- Change of Ownership applications
- Advice on and preparation of SmPCs, labelling and leaflets
- Free Sales Certificate Applications
- Liaison with Regulatory Authorities
- Dossier audits & Due diligence
- CMC advice
- Medical Device Clinical Evaluation reports
- Cosmetics Safety Assessments
If there are any additional services which would be of interest please do not hesitate to contact us using the form provided.
