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LOCAL-REGULATORY-AS-A-SERVICE

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

Local regulatory: DACH region
Local regulatory: Portugal

Local regulatory: DACH region

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 authorisation and marketing for pharmaceuticals – since the complex regulations can quickly become a challenge, even for locals.

Our services for Germany, Austria, and Switzerland

Regional regulatory strategy

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

Preparation for product launch

We 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.

Information texts & data base entries

We 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.

IFA

We 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.

Marketing authorisation maintenance

We advise you, and together with you design the best course of action to ensure that your marketing authorisation 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.

Informationsbeauftragter

We take on 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.

Review of promotion materials

We carefully review the promotion materials for your product to ensure that the applicable regulations – for pharmaceuticals, medical devices or food supplements – are complied with.

Compliance of printed packaging materials

We check printed packaging materials in particular to ensure that all current guidelines are complied with here, as well.

Local regulatory: Portugal

Like every market, Portugal has its own special rules. With our long-standing experience, we know our local market 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 services for Portugal

Regional regulatory strategy

Our experts work with you to develop a regulatory strategy specifically for Portugal.

Preparation for product launch

We 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, including advanced eCTD publishing and hosting of your dossiers.

Information texts & data base entries

We take care of the maintenance of producti nformation texts and database entries so that they are always up to date in terms of content and legal aspects.

Infarmed databases

We support you in all matters concerning the databases of Infarmed (e.g. SMUH-ALTER, SIATS, SIDM) for your product, or take care of the formalities with other relevant authorities in your target market.

Marketing authorisation maintenance

We 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 law general act concerning medicines for human use in article 77º, no3.

Check of information materials

We 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.

Review of promotion materials

We carefully review the promotion materials for your product to ensure that the applicable regulations – for pharmaceuticals, medical devices or food supplements – are complied with.

Compliance of printed packaging materials

We check printed packaging materials in particular to ensure that all current guidelines are complied with here, as well.

Get in touch now!

Contact us for assistance in our local markets.

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