experienceMedicinal Product Development

s4s prepares all scientific expert opinions, evaluations and documentation required by the client during the development of medicinal products. The many years of medicinal product development experience of our experts provides them with an in-depth knowledge of all official requirements in the areas of quality, non-clinic and clinic. We share this knowledge with our clients, advising them regarding the strategy and feasibility of their projects.

The acceptance of our work by national and international authorities has been confirmed by our clients through many years of co-operation.

We prepare all required expert opinions, evaluations and documentation for chemically defined substances, biotechnologically prepared medicinal products, herbal medicinal products and endogenous substances. This includes all pharmaceutical forms and indications from A to Z, as well as all types of applications.

Our experts base their work on client data and conduct extensive literature searches after consulting with the client.

 

The services of s4s in the area of medicinal product development include:

  • Literature searches in all relevant databases
  • Consulting in our areas of expertise
  • Scientific expert opinions e.g. toxicological expert opinions, scientific expert opinions for questions related to quality, non-clinic and clinic for R&D, medicinal product development and marketing authorisation (e.g. within the scope of deficiency notices) hazardous substance classification according to the ordinance on hazardous substances...
  • Investigator's drug brochures, investigational medicinal product dossiers, clinical trial application
  • Documentation of the Paediatric Investigation Plan (PIP) with a development programme for use with children, studies involving children, waiver, deferral in accordance with EC 2008/C 243/01
  • Briefing documentation for meetings with authorities
  • Evaluation of existing documentation regarding approval suitability, identification of gaps
  • Medical opinions
  • Medical writing for non-clinical and clinical studies (e.g. study design, study protocol, final reports, publication in trade journals)