Regulatory Affairs 1200×500

HANDLING OF REGULATORY AFFAIRS


Before you can launch your pharmaceutical on the market, you need the corresponding authorization to ensure the safety of your product. For a successful registration process, a wide variety of issues need to be taken into account: from planning the overall strategy, to preparing and analyzing data from different fields, to submitting the dossier to the authorities.


Market authorization is not a one-time affair:

Even after receiving a market authorization, there are regulations, such as on packaging and advertising materials or in the event of unexpected side effects, that must be complied with. We support you with our services in all relevant areas.

RA-Strategy-As-A-Service

You should not wait until your product is (almost) ready for use before dealing with the marketing authorization process. THE FORCE is there to help you with all strategic questions right from the start. This way, challenges can be solved proactively instead of causing time-consuming and costly problems later on.

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Lifecycle-As-A-Service

Regulatory affairs do not only concern newly developed products and technologies when they are first submitted. Even subsequently, market authorizations must be maintained, and adapted to any changes made. THE FORCE accompanies your product through its entire lifecycle.

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DACH-Regulatory-As-A-Service

Every market has its own laws. With our many years of experience, we know our local markets – Germany, Austria and Switzerland – inside out and always keep up to date on all legal issues to guide you safely through the DACH region.

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Applicant-As-A-Service

As a pharmaceutical company with a manufacturing license and a fully functional PV system, our sister company is perfectly equipped to submit your MA Application and to carry out the procedure on your behalf – while you can focus on your core activities.

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Serialization-As-A-Service

Serialization offers protection against counterfeit drugs. We protect you from getting overwhelmed by the whole process and take care of everything from the registration with European and country-specific authorities to daily activities concerning serialization.

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