2 Sevices
Leffel Consulting Group, LLC
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.
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
