Regulation in the EU
The environment of healthcare regulation is constantly evolving not only in the EU but also in all member states.
We provide professional services in all areas that may be related to health care.
Our specialized companies are a guarantee of professionalism and quality.
REGULATION IN THE EU
The environment of healthcare regulation is constantly evolving not only in the EU but also in all member states. Orientation in legislation, processes, procedures and their time and economic context is not easy. In order to properly evaluate all possibilities and impacts, this area needs to be devoted to the necessary capacity. The need to take possible regulation into consideration is necessary for the early phases of research projects and then throughout the life cycle of the product.
Our background allows us to provide professional services in all areas that may be related to health care. These include, in particular, humane medicinal products, medical devices, food supplements, novel food or cosmetics. You can also contact us with veterinary products. We provide services across the EU and other countries.
The aim is to correctly define the directions and potential products of biomedical projects in terms of regulation and to put projects into the regulatory context.
Information gathering - A structured template serves to collect the basic information needed to assess the translation process and to build a strategy.
Analysis and recommendations - analysis, addition and recommendation of the procedure.
Translating Strategies - All aspects of the translation process, project planning and project management to eliminate risks and to organize all aspects of achieving the goal.
Our team of clinicians, pharmacologists, and consultants from other specialized workplaces offers service focused on:
Assisting in Trial Design and Protocol Development
Clinical Study Coordinator
Education and seminars (GCP, Clinical Trials in Practice, Pharmacology)
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The project does not end with the registration. Successful product marketing is another area and has a number of pitfalls.
Economic Analysis in Health Care
Consultation on strategic plans
Preparation of payment dossiers for reimbursement procedure
Pricing and reimbursement strategy
Post-marketing research (doctors, patients)
The main goal is to ensure safety. Monitoring and reporting of side effects that may occur during a treatment are to prevent potential risks, protect the patient, physician and the medicinal product.