Regulatory Writing

A precise understanding of regulatory guidelines and the specific requirements in the respective therapeutic area are essential prerequisites for the successful authorisation of your medicinal product or medical device. Together with our highly qualified medical writers, you will be able to successfully master these special challenges in the regulatory pharmaceutical field.

Documents for regulatory authorities

Regulatory documents require precise, highly scientific writing as well as consistent and transparent presentation of key messages within the different documents. Whether regulatory submissions or individual dossier modules, the excellent communication skills and deep medical-scientific understanding of our industry-experienced medical writers enable us to produce your regulatory documents at the highest level of quality.

Our Services:

  • Complete and of high quality: Preparation and drafting of regulatory documents
  • Relevant for approval: Preparation of individual dossier modules (medicinal products)
  • Evidence-based: Clinical evaluation of medical devices (CER)
  • Focused: Support in the submission of marketing authorisation applications
  • Systematic: Preparation of answer catalogues to questions from regulatory authorities
  • In a nutshell: Documents for scientific consultations
  • Routinely: Communication with regulatory authorities (e.g. ethics committees)

Preparation of study documents

Within the scope of studies relevant for approval, a large number of technically demanding study documents have to be prepared both in the pre-clinical and post-clinical phase. The expertise of our medical writers allows these documents to be drafted promptly, professionally and in accordance with the respective guidelines.

Our Services:

  • Detailed and guideline-compliant: Preparation of study protocols (CSP)
  • Comprehensible and lay-friendly: Patient information and Informed Consent Form (ICF) and clinical trial summaries (Lay Summaries)
  • Concise and objective: Investigator Brochures (IB)
  • Structured and consistent: Management of amendments
  • Precise and thorough: Preparation of study reports (CSR)
  • At a glance: Summary of study results