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DACH-REGULATORY-AS-A-SERVICE

You would like to register your product for Germany, Austria or Switzerland?
Benefit from our experience in our local markets.

As with all markets, special rules apply to the countries in the DACH region. With our many years of experience, we know our local markets inside out and always keep up to date with all regulatory aspects. This allows us to safely accompany you in all questions of market authorization and marketing for pharmaceuticals – since the complex regulations can quickly become a challenge, even for locals.


Our experts work with you to develop a regulatory strategy specifically for Germany, Austria and Switzerland, and...

...support you on the way to your product launch and ensure that all regulations are already taken into account and fulfilled in the preparation phase.
...take care of the maintenance of product information texts and database entries so that they are always up to date in terms of content and legal aspects.
...support you in all matters concerning the IFA (the information service provider for the pharmaceutical market in Germany), such as the allocation of the necessary Pharmazentralnummer (PZN, the local number of a pharmaceutical) for your product or take care of the formalities with other relevant authorities in your target market.
...advise you and together with you design the best course of action to ensure that your marketing authorization does not expire because your product was not launched within the specified timeframe, as stated under the Sunset Clause defined by the German Medicines Act.
...take over the function of Informationsbeauftragter (“Information Officer”) according to §74a AMG for Germany. This way, we ensure that your pharmaceuticals comply with the applicable laws on labeling, package leaflets, expert information and advertisements, and that no misleading names, specifications or presentations are used.
...carefully review the promotion materials for your product to ensure that the applicable regulations – for pharmaceuticals, medical devices or food supplements – are complied with.
...check printed packaging materials in particular to ensure that all current guidelines are complied with here, as well.

Contact us

for assistance in our local markets.

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