TentaConsult Pharma & Med GmbH

TentaConsult is your reliable partner for regulatory strategies, market access and sustainable life cycle management.

With our comprehensive expertise, we support manufacturers of medical devices, pharmaceuticals, combination products, food supplements and cosmetics from the initial product idea through to long-term market surveillance in accordance with national and international requirements.

TentaConsult Pharma & Med GmbH is a specialist consultancy for regulatory issues in the life sciences sector. With around 30 employees at its Münster and Martinsried sites, TentaConsult supports manufacturers in the development, certification and market surveillance ofmedical devices as well as in the development, approval/registration and regulatory, safety and quality-related support ofmedicinal products throughout the entire product life cycle.

In the field of medical devices, we support our clients from the product idea and development phase through the preparation of the technical documentation and conformity assessment phase to certification and post-market surveillance of the products (vigilance and PMS). On request, we can take on the role of EU authorized representative in accordance with MDR Article 11 or provide a QMB or PRRC in accordance with Article 15, advise on regulatory or clinical strategies, biocompatibility issues, quality and risk management systems and carry out audits on request. If required, we also act as a legal manufacturer.

For medicinal products, we offer comprehensive regulatory support for national and international approvals and life cycle management. Our services include the preparation and maintenance of marketing authorization dossiers, the qualification of the supply chain including the performance of audits as well as the implementation and continuous maintenance of quality and pharmacovigilance management systems. In addition, we take on responsible roles such as EU QPPV, Information Officer, Responsible Person for Wholesale or Qualified Person.

A particular strength lies in our expertise in the area ofcombination products, where we offer integrated regulatory strategies at the interface between medical devices and medicinal products. Advice on regulatory requirements forfood supplements andcosmeticsalso complements our service portfolio. Both German locations are ISO 9001:2015 certified. TentaConsult also has a manufacturing authorization according to § 13 AMG for the release of sterile medicinal products.

The company is particularly characterized by its interdisciplinary expertise, practical solutions and integration into the internationally active Tentamus Group - including access to a network of accredited laboratory partners. The aim is to implement regulatory requirements not only in accordance with standards, but also in an economical and user-friendly manner.

In addition: TentaConsult is an active member of industry initiatives such as Pharma Deutschland e.V. and Bayern Innovativ. As part of the Tentamus Group, the company offers access to an international network of accredited testing and laboratory services.