Medical Affairs – Medical Writing

 

We communicate science. What’s your super power?

Our Medical Affairs employees are your point of contact for medical and scientific questions of all kinds.

We make sure that:

  • Your documents correspond to the current specifications
  • The legal framework conditions and guidelines are followed
  • The medical-scientific information is correct and up-to-date
Medical Affairs

 

Medical Writing communicates clinical and scientific data as well as scientific information. It is therefore essential to be familiar with product development, the legal and technical principles of clinical trials and current regulatory practice. A clearly structured, precise and effective approach is also required.
It is therefore essential to be familiar with product development, the legal and technical principles of clinical trials and current regulatory practice. A clearly structured, precise and goal-oriented way of working makes it possible to create accurate documents of the highest standard with a high level of content.

We serve many masters: Medical Writers work at the interface between Research & Development (R&D) and Marketing & Sales (M&S) and cooperate tightly with Regulatory Affairs and Pharmacovigilance departments.

What does DREHM Pharma offer for Medical Writing?

Team Medical Writing [Meet the Team!][8]

Team Medical Writing Meet the Team!

Our range of services includes:

Medical Affairs - Services

  • Production of scientific and medical texts of all kinds
  • Expert Reports (CTD modules 2.4 to 2.7) or statements for preclinical and clinical use (e.g. to support variations or an Rx-OTC switch)
  • Literature research
  • Provision of medical and scientific information on medicinal products
  • Response to medical enquiries
  • Assessment of existing documents for approval
  • Clinical Evaluation of medicines and Medical Devices
  • Production / revision of technical information and package inserts
  • Medical statements (e.g. to answer questions from authorities)
  • Risk Management Plan (RMP)
  • Aggregate Reports (PSUR, ACO)
  • Dossier preparation for dietary foods for special medical purposes (FSMP)
  • Lecturing of scientific papers
  • Specialized medical and scientific translations

We are also happy to pass on our expertise to our customers in the form of lectures or training courses.

Don’t find your question listed here? Ask us anyway, our members of staff will be happy to advise you!

We are happy to share our experience with you!