Regulatory Affairs
Diapharm is a full-service provider for all aspects of regulatory affairs in the sectors medicinal products, medical devices, cosmetics, food supplements and foods for special medicinal purposes.
Are you unsure which marketing strategy makes the most sense for your new product?
Or are you looking for the perfect partner to obtain marketing authorisation for your product?
We will advise you on all regulatory issues so your products can be placed strategically (also as a borderline product), brought to the market quickly and maintained.
Our services in the Regulatory Affairs sector include:
Regulatory strategies
We evaluate your product and identify the ideal strategic and regulatory marketability approach, including evaluating the product claims and/or indications you are intending to use.
National / international regulatory procedures
We manage all phases of acquiring marketing authorisation for your regulatory approvals projects, including national, MRP, DCP, centralised procedures (EMA) or variations.
Readability user testing (RUT)
We provide you with validated readability user testing in German, English or Romanian.
Maintenance of authorisations / dossiers
We undertake the maintenance of your marketing authorisations (dossier maintenance), including updating of marketing authorisation documentation, reformatting from NTA to CTD to eCTD, providing expert reports and processing deficiency letters.
Function as marketing authorisation holder
We are a fully established pharmaceutical company, in accordance with German law, and we assume all the duties and responsibilities of a marketing authorisation holder (MAH), including serving as a qualified person for pharmacovigilance, information officer and qualified person.
