Medical Writing

We provides expert medical writing services:

Regulatory Medical Writing

  • Literature Reviews
  • Clinical Development Plan
  • Risk Management Plan
  • Benefit Risk Assessment Report
  • Investigational Medicinal Product Dossier
  • Patient Safety Narratives
  • Drug Safety Update Report (DSUR)
  • Annual product reviews (PSUR)
  • Standard Operating Procedures (SOPs)
  • Translations of Regulatory Documents

Clinical Medical Writing

  • Clinical Study Report
  • Case Report Form
  • Investigator Brochure
  • Regulatory Applications and submissions
  • Informed Consent Form
  • Clinical Trial Protocol

Scientific Communications & Publications

  • Poster
  • Meeting & Conference Report
  • Manuscript
  • Abstract
  • Educational materials

Contact

Talk to a clinical expert

Don’t hesitate to contact us if you have a clinical program or project coming up. We will provide you with more information on our operations model and provide you with a custom-made and budget-effective solution.

Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.