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Recht

Services

With many years of experience in the areas of product development and regulatory affairs, an interdisciplinary education and various patent applications, I am your competent contact for regulatory affairs of food supplements, pharmaceuticals, medical devices and functional foods in germany and europe.

Your benefits 

In practice, the placing on the market of food supplements, pharmaceuticals and medical products involves considerable legal uncertainties in view of the high level of complexity in the area of tension between law and natural sciences. Many of the ingredients used, especially plant extracts, can be used ambivalently, so that the type of preparation, the dosage, the intended use and the combination of ingredients often determine the legal classification and marketability of a product in germany and europe. The generally abstract regulatory character of the relevant legal norms is not comprehensive in many cases, which is why it is very often important to examine the individual case in detail. An expert opinion helps to clarify disputes and can also be very useful with regard to existing liability risks before the product is placed on the market. 

Services at a glance 

Testing and certification of marketability

Activities as responsible for the traffic of narcotics

Opinion on the effect as  functional drug

declaration checks

Review of Health Claims

Patent Valuation

QMS assessment 

Delimitation report for AM, NEM, MP

Working as an external wholesale representative 

Expert opinion on the classification of medical devices

Identification of unknown ingredients

Reviews of professional information

Expert opinions on the state of the art of inventions for patents

Evaluation of clinical studies

Classification report for plant extracts & ingredients

laboratory analyses

Examination of the pharmacy customary

Evaluation of plant extracts

Scientific Opinions

Expert opinion on the inventive step in patents

Assessment of stability tests

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