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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

We competently and reliably equip your pharmaceutical and healthcare products with all regulatory requirements for successful and rapid market access.

 

Quality Management

We support the establishment and optimisation of your QM systems and everything that goes with them in a responsible and experienced manner.

 

Clinical/Medical Affairs

We prepare meaningful clinical and medical reports and documentation for the scientifically substantiated assessment of your products.

 

Vigilance / Surveillance

We take responsibility for the safety monitoring and risk assessment of your products at every stage of their life cycle.

Tentamus laboratories in your vicinity