We offer the multidisciplinary services covering all aspects of regulatory affairs including pre-authorisation, post-authorisation as well as handling of the registration process of medicinal products (human/veterinary) and medical devices across all application types and various pharmaceutical forms. We also assist in placing dietary supplements or cosmetics on the market.
Scope of Regulatory Affairs services:
- Assessment of documentation readiness for the registration procedure.
- Management of submitted registration applications.
- Opinions on the optimal registration route for the Client’s products including assessment of borderline products.
- Planning, organization and active participation in Scientific Advice and pre-submission meetings.
- Preparation of registration dossier (modules 1-5) for the national and European procedures in CTD/eCTD/NeeS format.
- Support and verification of medicinal product invented name for compliance with national and European requirements.
- Active communication with the national Competent Authorities as well as with EMA.
- Verification of package leaflets and mock-ups/specimens for compliance with the national requirements.
- Documentation conversion into eCTD/NeeS format.
- Preparation of summary of product characteristic, product information leaflet and labelling based on QRD templates.
- Readability tests preparation and conduct (protocols, questionnaires and reports from PIL readability testing, bridging reports).
- Proof reading of mock-ups in line with the national requirements.
- Polish/English and English/Polish documentation translations for the purpose of registration/post-authorisation procedures.
- Handling of registration process.
- Preparation and submission of an application for withdrawal from the effects of Sunset Clause.
- Rx to OTC switch.
- Regulatory Outsourcing and much more…