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We Write You Cure

Biologics | Cell Therapy | Medical Devices | Small molecules

We’re scientists, researchers, engineers, and prolific writers. We know the business and we hit the ground running.

A team of our very best writers tackle assignments together to bring decades of experience to your project. Not only do we understand the technical content, but we know what questions to ask and how to find answers.

biologic cell therapy medial devices small molecules

Regulatory
agencies expect perfection and perfection is what we do best.

Services and Writing Projects

medical devices
Medical Devices

Our CER production process allows us to generate high-quality CER documents with impressive speed and accuracy. Our teams work in parallel so tasks are finished simultaneously.

chemistry, manufacturing, and controls team
Chemistry, Manufacturing, and Controls (CMC) Team

Our CMC team is full of scientists and engineers who can write. Each CMC writer has over ten years of biotechnology process development, manufacturing, quality, and/or pilot plant experience. We understand how to document a process and tie together Critical Quality Attributes and Critical Process Parameters into a comprehensive control strategy that can be validated.

CMC module 3
CMC / Module 3
  • Investigational New Drug (IND)
  • Investigational Medicinal Product Dossier (IMPD)
  • Biologics Licensing Application (BLA)
  • Marketing Authorization Application (MAA)
  • New Drug Application (NDA)
  • Drug Master Files (DMF/EDMF)
  • Technical reports and SOPs
  • Annual reports
medical device
Medical Device
  • Clinical Evaluation Reports (CER)
  • Chinese CER (CFDA-compliant)
  • Investigational Device Exemption (IDE)
  • 510(k)
  • CE labeling
general clinical
General Clinical
  • Clinical protocols
  • Clinical Study Report, Phase I – IV (CSR)
  • Clinical Trial Disclosures
  • Annual reports
  • Labeling
  • Pediatric Study Plans
  • Pediatric Investigational plans
  • Development Safety Update Reports (DSUR)
  • Patient narratives
  • Clinical trial protocols
  • Informed Consents / Assents
  • Investigational Brochures

About us

about us

GMWT was founded in 2013 by Emily Stephens and has steadily grown into a 20+ person company. Using a team approach, we provide consistent long term availability and flexibility to respond quickly to your projects. We are trained manufacturing engineers and lab scientists who have spent cumulative decades preparing these documents. We don’t simply write material, we understand it on a fundamental level that enables us to be a go-to source and an information liaison within your company.

Contact

contact Global Medical Writing and Translation

Global Medical Writing & Translation
27721 105th Ave SE
Kent, Washington  98030
USA

Phone +01-253-243-6121

info@globalmwt.com