Why Choose Us

Choosing FMD K&L as your partner of choice to provide either a single service offering or a more comprehensive range of services, is the first step in the right direction for success with your product development and / or regulatory submissions.  Our diversified range of services encompass Data Management, Biostatistics, Statistical Programming, CDISC-compliant eSubmission, Drug Safety, Medical Writing, and Clinical Operations. 

Because we are constantly striving to raise the standard of excellence through efficiency, innovation, and expert attention to detail, we provide comfort in your mind that your job will be delivered on time, within budget, and at the highest quality standards you have come to expect.  Additionally, by partnering with us for your next project, you will gain the insight and experience from our pool of experts who have years of industry knowledge.  Our experts include a wide range of PhD level team members that are at the forefront of your project regardless of its size or scope.  

As you can see, our track record shows why partnering with us is the right decision.

Agency Submissions (past 36 months) 

  • 17 US NDAs: 11 have been approved and 6 are pending
  • Submissions in other regions include EMA, PMDA , Canada, Mexico, Singapore, South Korea, and others 

Therapeutic Area Experience

  • Oncology
  • Anti‐Inflammatory / Pain 
  • Neurology / CNS
  • Cardiovascular
  • Gastroenterology 
  • Ophthalmology 
  • Allergy
  • Vaccine
  • Anti‐Infective
  • Diabetes and Metabolic Disease
  • Dermatology
  • PK / PD