Medical Writing

TKL’s in-house medical writing professionals provide writing and publishing support in preparing regulatory documentation for submission to international regulatory agencies in electronic Common Technical Data (eCTD) format and according to International Conference on Harmonisation (ICH) guidelines for structure and content of clinical study reports (ICH-E3).

Our medical writing services, include:

  • Briefing packages and supplements for investigational new drug (IND) and investigational device exemption (IDE) submissions
  • New drug application (NDA) and premarket approval (PMA) submissions
  • Investigator’s brochures (IB)
  • Clinical protocols
  • Clinical study reports (CSR), investigators’ safety/efficacy summaries (ISS/IES)
  • Publication manuscripts
  • Literature reviews
  • Poster presentations

Our medical writing experience covers many therapeutic areas, including:

  • Allergy/immunology
  • Cardiology
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Infectious disease
  • Metabolism/nutrition
  • Musculoskeletal
  • Nicotine replacement therapy
  • Ophthalmology
  • Pain management
  • Pediatric
  • Podiatry
  • Respiratory disease
  • Women’s health

 

Download our AMWA presentation on Interventional Trial Design.

Brochure

Download our Data Management, Biostatistics & Medical Writing Services Brochure.