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

Individualized Services

Leffel Consulting Group, LLC offers a diverse range of consulting services. Contact us for a planning session to learn about what we can offer your company.

 

  • Advising on strategic plans to advance development of pharmaceutical programs to protect against biological, chemical, radiological threats, or other emerging infectious diseases
  • Streamlining programs by navigating the FDA Animal Rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) – from the first proof-of-concept efficacy study to preparing for the Investigational New Drug application
  • Providing expert advice on responsible scientific approaches, study designs, data analysis and appropriate endpoints for natural history and nonclinical efficacy studies
  • Consulting on aerobiology studies, inhalational infectious disease models, characterization of natural history and designs for all routes of exposure
  • Auditing subcontractors for compliance with Good Laboratory Practices, protocol conformity and overall scientific integrity of data and documentation
  • Representation at U.S. Government funding and regulatory agency meetings

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

 

 

 

 

 

 


How to Find Us:

Conveniently located in the Washington DC-Metro Area

and near Maryland's Biotechnology Corridor

 

+1 (540) 486-4723

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