FDA Animal Rule consultant
FDA Animal Rule consultant
Leffel Consulting Group, LLC
Leffel Consulting Group, LLC

Welcome to the Leffel Consulting Group

The Leffel Consulting Group, LLC provides services to pharmaceutical and biotechnology companies desiring external assistance in preclinical and nonclinical programs. We provide expertise in the areas of traditional biologic and vaccine development, in addition to medical countermeasures for biological, chemical or radiation/nuclear disasters and emerging infectious diseases. Scientific and regulatory guidance is provided in the areas of: FDA Animal Rule navigation including model development, inhalational routes of exposure, appropriate designs for successful efficacy studies, interpretation of data and preparing documents suitable for both government and investor audiences.

 

At Leffel Consulting Group we offer a strategic partnership with each client and strive to provide focused and personalized service. Contact us today to schedule a planning session that will meet your scope and timelines.

Offering a unique combination of experience

  • Product development planning for medical countermeasures (MCMs) ... advancement from the research bench to the patient's bedside
     
  • Oversight of nonclinical efficacy and preclinical toxicology and pharmacokinetic studies
     
  • Advising on aerobiology studies and characterizing natural history models for appropriate routes of exposure; applying experience from hands-on work in Biosafety levels 2-4 laboratories
     
  • Learn more about our combined government and industry experience

Providing focused personalized support

  • Superior quality in all deliverables, tailored to requirements of private investors, government funding or regulatory agencies
  • Strategic partner that recognizes the importance of fast turn-around times and compressed timelines
  • Network of experts to ensure fluent transition from basic research to advanced development of MCMs

Strategic planning of product development programs...from the bench to the patient.

 

 

 

 

 

 


How to Find Us:

Located in central Virgina with convenient accessibility to the the DC metro area, small businesses and academic interests.

 

+1 (540) 247-4874

Print Print | Sitemap
© Leffel Consulting Group, LLC