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.
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.
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 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.
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.
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.