Regulatory submissions require clear, accurate and compliant documents

Medical Writing

Zwiers experts have the writing skills as well as attention to detail and timelines
  • Clinical study protocols (CSPs)
  • Clinical study reports (CSRs)
  • Common Technical Document (CTD) modules for Marketing authorization applications (MAAs) and New Drug Applications (NDA)
  • Investigational New Drug (IND) and Clinical Trial Applications (CTA)

In addition, we perform and deliver the related:

  • Literature analyses
  • Quality control
  • Manuscripts for publication

We write for you, but collaborate with you to ensure high-quality content that meet not only your expectations but also those of the health authorities

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Zwiers Regulatory Consultancy is a ProductLifeGroup Company

ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.

Product LIfe Group