TentaConsult is your reliable partner for regulatory strategies, market access, and sustainable lifecycle management.
With our comprehensive expertise, we support manufacturers of medical devices, medicinal products, combination products, food supplements and cosmetics from the initial product idea to long-term market surveillance in accordance with national and international requirements.
TentaConsult Pharma & Med GmbH is a specialised consulting company on regulatory matters in the life sciences industry. With around 30 employees based in Münster and Martinsried, TentaConsult supports manufacturers in the development, market access and post-market surveillance of medical devices, as well as in the development, marketing authorisation/registration, and regulatory, safety and quality life-cycle maintenance of medicinal products.
In the field of medical devices, we support our clients from the product idea and development phase, through the preparation of the technical documentation, the conformity assessment process, certification, and post-market surveillance systems after placing the device on the market. Upon request, we assume the role of EU authorised representative in accordance with MDR Article 11 or provide a quality management representative or PRRC in accordance with Article 15, advise on regulatory or clinical strategies, biocompatibility issues, quality and risk management systems, and conduct audits as needed. If required, we may act as the legal manufacturer.
For medicinal products, we offer comprehensive regulatory support for national and international marketing authorisation and life cycle management. Our services include the preparation and maintenance of marketing authorisation dossiers, supply chain qualification including conduction 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 with combination products, where we offer integrated regulatory strategies at the interface of medical devices and medicinal products. In addition, advising on regulatory requirements for food supplements and cosmetics complements our service portfolio. Both German sites are certified according to ISO 9001:2015. In addition, TentaConsult holds a manufacturing authorisation in accordance with § 13 AMG for the release of sterile medicinal products.
The company stands out for 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 compliance with standards, but also in an economical and user-friendly manner.
- Overview of our services in the field of medical devices
- Overview of our services in the field of pharmaceuticals
TentaConsult is an active member of leading industry initiatives such as Pharma Deutschland e.V. and Bayern Innovativ. As part of the Tentamus Group, the company provides access to an international network of accredited testing and laboratory partners.
