SciencePharma offers multidisciplinary services covering all aspects of regulatory affairs, including pre-authorisation stage of a medicinal product (human/veterinary). We also have all the conditions to support your company in the field of regulations regarding medical devices, cosmetics and supplements. We also assist in placing medical devices, dietary supplements or cosmetics on the market.
Scope of pre-authorisation services:
- Regulatory strategy preparation indicating the optimal registration path, registration category, costs and the chances of the project success
- Assessment of documentation readiness for the registration procedure – so-called ‘dossier Gap analysis’
- Planning, organization and active participation in Scientific Advice and pre-submission meetings
- Product Information management covering both: Readability test & Bridging report, Product Information Preparation & Verification (including mock-ups) & Translation, and Educational materials verification,
- Preparation of registration dossier (modules 1-5) for the national and European procedures in CTD/eCTD/NeeS format encompassing starting from Application Form Preparation, through Quality Overall Summary (QOS) & Module 3 preparation ending with the preparation of non-clinical & clinical part of dossier, and much more.