HANDLING OF REGULATORY AFFAIRS
Before you can launch your pharmaceutical on the market, you need the corresponding marketing authorisation 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 analysing data from different fields, to submitting the dossier to the authorities.
Market authorisation is not a one-time affair:
Even after receiving a marketing authorisation, 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 authorisation 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
Regulatory affairs do not only concern newly developed products and technologies when they are first submitted.
Even subsequently, marketing authorisations must be maintained, and adapted to any changes made – from the consideration of new scientific findings to the adjustment of batch sizes.
THE FORCE accompanies your product through its entire life cycle.
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
To authorise your medicinal product within in the EU or the EEA, a Marketing Authorisation Application (MAA) must be submitted.
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
Scientific-Writing-
As-A-Service
The market launch of a drug, medical device or food supplement is complex: many studies have to be carried out and data collected to prove that a product is effective, safe, and of high quality.
THE FORCE helps you to prepare the data in an understandable manner and to present it in the best possible way so all information is optimally understood by the recipient.
Dossier-Writing-
As-A-Service
A complete and well-written approval dossier for a medicinal product or the technical documentation for a medical device is an important step on the way to the market launch.
It also follows complex rules and guidelines. THE FORCE ensures that you include the right amount of detail and that people enjoy reading your application.
