About Us

FMD K&L is a global contract research organization serving the pharmaceutical, biopharmaceutical, medical device, and consumer healthcare industries.
We provide consulting, services, platforms, and solutions addressing our clients’ critical business and scientific needs in 7 broad areas:
  • Data management, biostatistics and statistical programming
  • Medical writing
  • Regulatory affairs
  • Product safety, toxicology and pharmacovigilance
  • Medical affairs
  • Clinical operations
  • Quality compliance, risk management, information technology services and application development
FMD K&L is designed specifically for global healthcare product development of pharmaceutical, biopharmaceutical, medical device, cosmetic, and nutraceutical products. We apply an efficient local/global methodology deploying talent through our central management to deliver services across the Americas, Europe, and Asia. Our strategically located global delivery centers provide:
  • Rapid startup
  • Scalability
  • Flexible delivery models
  • A single point of contact

FMD K&L integrates data from multiple sites into a cohesive database supporting clinical research, product development, regulatory submissions, and post-marketing surveillance. We seamlessly resolve differences in regulations, languages, and cultures to clarify the safety and efficacy of your product. FMD K&L provides state-of-the-art expertise in every service and solution we offer, employing a professional team with outstanding academic credentials, a track record of exceptional results, successful NDA submission and commitment to the highest business ethics, quality and timeline fulfillment. Our comprehensive services, solid infrastructure, and veteran management make FMD K&L a partner you can trust to meet your local and global compliance requirements and drug development challenges.

Therapeutic area experience

  • Oncology
  • Anti‐inflammatory / pain
  • Neurology / CNS
  • Cardiovascular
  • Gastroenterology
  • Ophthalmology
  • Allergy
  • Vaccine
  • Anti‐infective
  • Diabetes and metabolic disease
  • Dermatology
  • PK / PD