Regulatory Affairs

Whether a product is marketed as an OTC medi­cine or as a food supple­ment is not impor­tant for most consumers. However, the regu­la­tory burden for market access varies considerably.

We advise our clients on how the choice of indi­ca­tion or marketability affects them in the long term.

As soon as all rele­vant options have been sounded out and eval­u­ated, our Regu­la­tory Affairs team will get down to work. With a sure hand, we take on all tasks and respon­si­bility for the approval, regis­tra­tion or certi­fi­ca­tion of your prod­ucts. We are also very familiar with the special require­ments for niche products.

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Quality Management

Clearly defined direc­tives specify the formal­i­ties for phar­ma­ceu­tical, medical device, food tech­nology or cosmetics-related quality manage­ment. However, the imple­men­ta­tion prac­tice of GMP, HACCP or ISO require­ments in compa­nies often holds consid­er­able poten­tial for improvement.

We provide advice on all aspects of quality manage­ment and risk manage­ment: In accor­dance with the existing struc­tures in the company, we support the estab­lish­ment of QM systems or review already estab­lished systems.

We carry out audits and training courses and develop effi­cient and prac­tical QM concepts on this basis. Parallel to this, we also offer customers the option of dele­gating respon­si­bility into our hands, such as the func­tion as whole­sale repre­sen­ta­tive or batch release.

Clinical / Medical

All indi­ca­tions, purposes and health claims are based on evidence-based scien­tific data.

If your own studies are required, our expe­ri­enced special­ists will advise you on the orien­ta­tion and struc­ture of an effi­cient study design that reflects the deci­sive factors for the infor­ma­tion to be obtained.

If your product is based on estab­lished active ingre­di­ents, we will research for you whether suit­able evidence has already been published and prepare mean­ingful liter­a­ture-based expert reports and documentation.

The toxi­co­log­ical and phar­ma­co­log­ical assess­ment of your prod­ucts is as well in expe­ri­enced hands with TentaConsult.

We are also happy to take on specific respon­si­bility for product state­ments as infor­ma­tion officers.
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Vigilance / Surveillance

The protec­tion and safety of patients and users is a top priority in the health­care industry and is legally stip­u­lated by complex regulations.

In order to meet the legal require­ments respon­sibly and reli­ably, we prepare scien­tif­i­cally based risk assess­ments and under­take market obser­va­tion for our customers’ drugs and medical products.

On behalf of our customers, we also assume respon­si­bility in rele­vant func­tions in the vigi­lance system, for example as QPPV or as a phased plan officer.
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