Services

Project Management

  • Product developments (medicinal, medical devices, cosmetics, nutritional/food supplements, herbals)
  • Programs e.g. implementation of new regulatory requirements to organizations or products

Scientific Writing

  • Clinical evaluation reports (CER) according to MDR including literature search, literature search reports, and related documents (CEP, SSCP, PMCFP, PMCFR, etc.)
  • Answers to deficiencies from Health Authorities or Notified Bodies
  • Justification documents
  • Expert reports & statements
  • Drug or medical device label development (CCDS, SmPC, IFU)

Scientific Consulting

  • Evaluations and reviews of ingredients, formulations, or health claims
  • Investigation of new benefit areas
  • Cosmetic safety assessments
  • Competitive analyses

Medical Communication

  • Abstracts and poster contents
  • Publications from manuscript to journal submission & follow ups
  • Conference reports

Education & Training

  • Presentations/slide-decks
  • Professional training (company internal or external e.g. of pharmacists)
  • Brochures/leaflets, detail aids for health care professionals or consumers

The services can be offered in

  • English
  • German
  • French
  • Greek