Marketing authorization

Global marketing authorisation services for human and veterinary medicines

Marketing authorisation applications for human and veterinary medicines

• National / Mutual recognition and Decentralised and Centralised procedures
• Modules 1 - 5 for human medicines
• Parts 1 - 4 for veterinary medicines
• Assistance in requesting scientific advice

Marketing authorisation renewals and extension and product maintenance

• Type IA, IB and II variations
• Line extensions and renewals
• Labelling mock-ups and proofreading for packaging materials
• Coordination of multi-language packages
• Preparation and updating of Summaries of Product Characteristics, Package Leaflets
• Translations into several European languages
• Notification of placing a medicinal product on the market

Pharmaceutical-Chemical services

• Evaluation, writing and updating of quality documentation for marketing authorisation purposes
• Evaluation / writing / submission / maintenance / renewals of required regulatory documentation (DMF/CEP) for conventional API’s in EU and USA

Readability of package leaflet user tests

• Designing / planning, conducting and reporting readability of package leaflet user tests

Electronic submissions

• eCTD, Nees and VNees
• Preparation / reformatting of a CTD / non-CTD format application into a CTD / an eCTD format documentation
• Product life cycle management of your eCTD format submissions within the eCTD tool

Pharmaceutical and medical expert statements

Consultation and training

• All the services mentioned above