Product Maintenance
We develop and review concepts for efficient and safe product maintenance. For medicinal products and for medical devices, cosmeceuticals and nutraceuticals. We advise and support you in every phase of market access – and beyond.
Right from the very first steps in the development of formulations, we contribute our specialist knowledge and creative impulses for the design of product properties. The feasibility of our concepts is always guaranteed: We are very familiar with the regulatory requirements of the various marketability options and are happy to take on the preparation of the necessary dossiers and documents – right up to clinical and medical documentation.
We also take responsibility for the establishment and maintenance of quality management systems in accordance with GMP, GLP and GDP requirements. With our international network of service laboratories, we are also ideally positioned for every aspect of analysis.
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.
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.
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 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.
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.