PRSG - Expert in Regulatory Affairs

PRSG - Expert in Regulatory Affairs

PRSG - Pharmaceutical and Regulatory Services GmbH – is a company that offers comprehensive services for all aspects of regulatory affairs in means of a One-Stop-Shop.

Our services comprise solutions for all questions concerning Regulatory Affairs in the sectors medicinal products (human and  veterinary), radiopharmaceuticals, medical devices class 1, cosmetics, nutritional and dietary supplements, foods for special medical purposes and wellness products, both at European and national level.


Our Team: Lydia Langkammer, Annemarie Moretti, Barbara Sturm (f.l.t.r.)

We can support you across a product's life cycle, either in assisting or leading function for partial or complete marketing authorisation projects.

PRSG unites experience, creativity, flexibility and high quality work at one point!

 

Service overview

    Consulting

    Information

    Dossier Creation

    Dossier Maintenance

    Applications
  

Whether you are new to regulatory affairs or looking for additional support, please do not hesitate to contact the PRSG!

We will provide the most appropriate solution for your individual project!

Principles

PRSG established an unique and specialized center where new ideas, all kind of regulatory issues, solutions and objectives will be exchanged and discussed on a high level of expertise and knowledge. We will evaluate your pharmaceutical product and identify the ideal strategic and regulatory marketability approach. Projects are realized according to the clients demands, corresponding regulations, directives and guidelines.

In order to keep our high standards and quality, PRSG works according to its internal quality management system, that was established and incorporated in October 2012. Benefit from our broad experience and access to experts in pharmaceutical engineering (Research Center Pharmaceutical Engineering GmbH).

PRSG is looking forward to supporting your regulatory work!

 

International

  PRSG is proud member of EuDRAcon - the European network of leading regulatory consultants.