Regulatory Affairs services
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 (check our area of expertise).
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…
Our services cover a wide range of regulatory needs, offering comprehensive support to clients throughout the product lifecycle.
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Preparation of complete registration dossiers for medicinal products
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Successful registration processes in national procedure
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Registration processes in European procedures
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Audits of registration dossiers
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Preparation of ASMF assessments in view of their registration readiness
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Scientific opinions/advices