Biologics Consulting Group, Inc.

Complete Regulatory Support for the Biologics Industry

Biologics Consulting Group, Inc.
Corporate Office - Alexandria, VA

The Virginia office of Biologics Consulting Group, Inc. serves as the executive headquarters for the company, providing all administrative and financial services as well as services associated with regulatory submission (IND, BLA, etc.) production and assembly.

The office is used by home-based BCG Senior Consultants for client meetings and for company meetings and training sessions.

Main Office Staff:

James Kenimer, Ph.D. - CEO

Michael Salgaller, Ph.D. - President & COO

Kelly T. Boyle - V.P., Finance & Technology, Secretary, Teasurer

Kathleen Hewitt - Administrative Assistant

Daniel P. Offringa - Electronic submissions

Kelly H. Reich, M.S. - Project management, regulatory submissions (paper and electronic)

Melissa Saathoff - Administrative Assistant

Jessica P. Shaw - Financial Assistant

Carol Urps - Personnel Coordinator

Holli Vaughan, M.S., RAC - Project management, regulatory submissions (paper and electronic)

William F. Winslow - Attorney

Home-Based Senior Consultants & their areas of expertise:

Consultant	Expertise	Contact information
Kerin Ablashi, MS Consultant	project management, regulatory submissions	C (240) 683-0007
Ellen Areman, MS, SBB Senior Consultant	development of cellular biological products, especially hematopoietic, immunologic and stem cell therapies	C (410) 207-0531
Julia Barrett, MD, MPH Sr. Clinical Consultant	clinical product development, clinical trial design and execution, FDA licensure requirements, and medical monitoring	P (303) 679-6214
Wilson Bryan, MD Sr. Clinical Consultant	clinical development of drugs and biologics to treat neurological disorders	C (301) 767-5034
Blair Fraser, Ph.D. Senior Consultant	CMC (quality), drug and biologic product development and FDA submissions	P (240) 477-7826
Joseph C. Fratantoni, M.D. Sr. Clinical Consultant	providing clinical assistance with regulatory and product development matters involving biologics, with a focus on blood and blood-related products.	C (301) 919-7217
John Godshalk, MSE, MBA Senior Consultant	cGMP, chemistry, manufacturing, and controls, quality and management consulting	C (703) 485-6139
Melanie Hartsough, PhD Senior Consultant	nonclinical pharmacology and toxicology and preclinical development of biologic products	C (301) 742-3665
Calley Herzog Consultant	regulatory project management for all types of premarket submissions	C (720) 883-3633
John Jessop, Ph.D, MPH Senior Consultant	pharmacology-toxicology, regulatory affairs and product development for biologics and drugs	P (540) 76-0680
David Lin, PhD Senior Consultant	CMC (quality), product development, and FDA submission requirements	P (301) 299-2853
Steve Litwin, MD Sr. Clinical Consultant	clinical requirements for oncology, gene therapy and transplant-related drugs	P (202) 483-1284
Andra Miller, PhD Senior Consultant	CMC, regulatory and GMP requirements for cell and gene therapy products	P (301) 320-9537
Ian Millett, PhD, RAC Senior Consultant	Driving successful regulatory strategies for medical devices and combination products in the EU, Canada, and U.S	C (415) 260-5413
Reggie Neal Senior Consultant	facility inspections, facility validation and regulatory requirements	C (202) 294-8543
Peter Patriarca, MD Sr. Clinical Consultant	biological product development, clinical evaluation, and product lifecycle management	C (301) 233-3220
David Pepperl, PhD Senior Consultant	nonclinical pharmacology and toxicology and preclinical development of biologic products	P (301) 987-5627
Stuart Portnoy, MD Senior Medical Device Consultant	developing successful regulatory strategies for medical devices across a wide range of therapies	P (703) 466-0961
Pete Probst Senior Consultant	audits and inspections	P (301) 831-3007
Miriam Provost, Ph.D. Senior Consultant	Developing successful regulatory strategies for medical devices and combination products	P (703) 242-0459
Nadine Ritter, PhD Senior Consultant	analytical CMC technical and regulatory requirements and R&D/GLP/GMP laboratory quality practices for biotechnology products	C (240) 372-4898
Ann Sutton, MPH Senior Consultant	CMC, regulatory and product development for vaccines and live biotherapeutic products	C (303) 903-2097
Mike Williams Senior Consultant	regulatory and product development for viral products, specializing in all aspects relating to influenza virus vaccines	C (703) 216-7944
Larry Winberry, PhD Senior Consultant	quality systems, manufacture and control, and product development for biological products	C (248) 396-5818
Ruth Wolff, PhD Senior Consultant		P (301) 921-4160
Annie M. Zurbay, RN, MSN, ND Consultant	medical writing, clinical safety, product development, and in authoring the clinical sections of marketing applications	P (303) 449-3344