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Regulation in the EU

The environment of healthcare regulation is constantly evolving not only in the EU but also in all member states.

Our services

We provide professional services in all areas that may be related to health care.

Partners

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 SERVICES

Our subsidiary companies Regulatory House and ReKnoS Science are involved in providing regulatory services.

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.

TRANSLATIONAL STRATEGIES

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.

CLINICAL TRIALS

Our team of clinicians, pharmacologists, and consultants from other specialized workplaces offers service focused on:

  • Assisting in Trial Design and Protocol Development

  • Site Identification

  • Study Setup

  • Clinical Study Coordinator

  • Monitoring

  • Education and seminars (GCP, Clinical Trials in Practice, Pharmacology)

  • More on the ReKnoS website

REGISTRATION

Properly selected registration strategies and procedures can be crucial to the success of the project. Sufficient professional care is always a must.

MARKET ACCESS

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

  • Portfolio optimization

  • Preparation of payment dossiers for reimbursement procedure

  • Pricing and reimbursement strategy

  • Post-marketing research (doctors, patients)

PHARMACOVIGILANCE

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.

 

PARTNERS

Send Us an Email:

Contact:

Archie Samuel s.r.o.

Jeneweinova 51a,

617 00  Brno
Czech Republic

  • Šedý LinkedIn Icon

+420 534 008 052 

 

office@asamuel.eu

 

www.asamuel.eu

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