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:
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
 |
John
Godshalk, MSE, MBA
Senior Consultant |
cGMP,
chemistry, manufacturing, and controls, quality and management
consulting |
C
(703) 485-6139
 |
| Steven C. Kunder, Ph.D., DABT |
nonclinical pharmacology-toxicology and development for drugs, vaccines and biologic products. |
C (240) 750-5035
|
Melanie
Hartsough, PhD
Senior Consultant |
nonclinical
pharmacology and toxicology and preclinical development of biologic
products |
C
(301) 742-3665
 |
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
 |
Maritza
McIntyre, PhD
Senior Consultant |
manufacture,
control, and product development strategies for gene and cell
therapy products |
C
(301) 502-5021
 |
Andra
Miller, PhD
Senior Consultant |
CMC,
regulatory and GMP requirements for cell and gene therapy products |
P
(301) 320-9537
 |
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
 |
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
 |
View the consultants' Areas of Expertise
Contact
Information for the Virginia Office:
Tel:
800-485-0106 (in the U.S.)
Tel: 703-739-5695 (outside U.S.)
Fax: 703-548-7457
Contact: President & CEO, Jim
Kenimer, Ph.D.
Biologics
Consulting Group, Inc.
1317 King Street
Alexandria, VA 22314
US
Page
Updated:
June 12, 2008
|