Our services
Our subsidiary companies Regulatory House ans ReKnoS Science are involved in providing regulatory servicies.
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 cosmetisc. You can also contact us with veterinary procucts. 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.
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Information gathering – a structured template serves to collect the basic information needed to assess the translation process and to build a strategy
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Analysis and recommendations – analysis, addition and recommendation of the procedure
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Translational Strategies – all aspects of the translational 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 consultatnts from other specialized workplaces offers service focused on:
REGISTRATION
Properly selected registration strategies and procedures can be crucial to the success of the project. Sufficient professional care is always a must.
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Regulatory consultation
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Registration services
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MAH holder service
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Notification service
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eCTD Publication
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More on Regulatory House website
MARKET ACCESS
The project does not end with the registration. Successful product marketing is another area and has a number of pitfalls.
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Ekonomic Analysis in Health Care
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Consultation on strategic plans
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Portfolio optimization
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Preparation of payment dossiers for reimbursement procedure
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Pricing and reimbursement strategy
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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.
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Regulatory support
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Complete PhV services
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PhV system Introduction
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PhV System Maintenance
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PASS
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More on Regulatory House website
MARKETING AND DISTRIBUTION
For more than 15 years, we have been striving to bring innovative products to the market and thus contribute to the improvement of healthcare. Our customers are the most important large hospitals as well as outpatient specialists, we are a reliable partner of medical facilities in the Czech Republic, Slovakia and other countries.
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Market research - we look for innovative products from reputable suppliers around the world and then bring them to our market
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Import and distribution - we deliver products to medical facilities directly or through large distribution companies
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Marketing - we provide marketing support to all products in cooperation with the regulatory team so that all materials and activities comply with our legislation
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Promotion and education - an integral part of the work of our professional team is education and training, in cooperation with doctors we organize professional seminars, workshops and support the education of our doctors and nurses