HANDLING OF REGULATORY AFFAIRS
Before you can launch your pharmaceutical on the market, you need the corresponding marketing authorization to ensure the safety of your product. For a successful registration process, a wide variety of regulatory 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 marketing authorization, there are regulations, such as on packaging and advertising materials or in the event of unexpected side effects, to comply with. THE FORCE supports you with regulatory affairs consultancy 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.
Lifecycle-
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.
DACH-Regulatory-As-A-Service
Every market has its own laws. While we are familiar with many regions, we know our local markets – Germany, Austria and Switzerland – inside out and always keep up to date on all legal issues.
Combined with our years of experience in these markets, we guide you safely through the DACH region.
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.
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.
Information-Officer-As-A-Service
Whether labelling, package leaflet, expert information or advertising: scientific information about your medicinal products must be checked according to particular specifications. We provide an information officer for this task – as and when required.
MDR/IVDR-Compliance-
As-A-Service
The EU regulations on medical devices and IVDs have changed the requirements that manufacturers of medical devices have to meet.
Are you overwhelmed by the obligations these regulations bring along? We make sure that you implement them accordingly.