Complete Regulatory Support for the Biologics Industry
Search our Areas of Expertise Database and Find One Of Our Staff That Can Help
Click Here
Click The Office Name For More Information, Click Again To Close
|
Main Office
400 N. Washington Street
Alexandria, Virginia 22314
|
Tel (Outside U.S.) (703) 739-5695
Tel (In The U.S.) 800-485-0106
Fax (703) 548-7457 |
Biologics Consulting Group, Inc. -
Main Office
Alexandria, Virginia
The Alexandria, 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:
Kerin Ablashi, M.S.
Consultant |
Phone: 240-683-0007
E-Mail:  |
| Expertise in project management, regulatory submissions |
|
Julia Barrett, M.D., MPH
Senior Clinical Consultant (with MD) |
Phone: 303-905-5383
E-Mail:  |
| Expertise in clinical product development, clinical trial design and execution, and FDA licensure requirements. |
|
Shannon Beeby,
Administrative |
Phone: 703-739-5695
E-Mail:  |
|
|
Kelly T. Boyle,
Vice President |
Phone: 703-739-5695
E-Mail:  |
|
|
Blair A. Fraser, Ph.D.
Senior Consultant |
Phone: 240-477-7826
E-Mail:  |
| Expertise in CMC (quality), drug and biologic product development and FDA submissions. |
|
Joseph C. Fratantoni, M.D.
Senior Clinical Consultant (with MD) |
Phone: 301-919-7217
E-Mail:  |
| Expertise in providing clinical assistance with regulatory and product development matters involving biologics, with a focus on blood and blood-related products |
|
John R. Godshalk, MSE, MBA
Senior Consultant |
Phone: 703-485-6139
E-Mail:  |
| Expertise in cGMP compliance, facility design and regulatory requirements, quality assurance, audits/inspections |
|
Michael Gross, Ph.D, RAC
Senior Consultant |
Phone: 215-316-8394
E-Mail:  |
| Expertise in quality and regulatory affairs for drugs, biologics, medical devices, specializing in combination products. |
|
Melanie T. Hartsough, Ph.D.
Senior Consultant |
Phone: 301-742-3665
E-Mail:  |
| Expertise in nonclinical pharmacology and toxicology and preclinical development of biologic products |
|
Calley Herzog,
Consultant |
Phone: 720-883-3633
E-Mail:  |
| Expertise in regulatory project management for all types of premarket submissions. |
|
John J. Jessop, Ph.D., MPH
Senior Consultant |
Phone: 540-776-0680
E-Mail:  |
| Expertise in pharmacology-toxicology, regulatory affairs and product development for biologics and drugs |
|
James G. Kenimer, Ph.D.
President/CEO |
Phone: 703-739-5695
E-Mail:  |
| Expertise in regulatory strategy – FDA liaison |
|
David T. Lin, Ph.D., MBA
Senior Consultant |
Phone: 301-299-2853
E-Mail:  |
| Expertise in CMC (quality), product development, and FDA submission requirements |
|
Stephen D. Litwin, M.D.
Senior Clinical Consultant (with MD) |
Phone: 202-483-1284
E-Mail:  |
| Expertise in clinical requirements for oncology, gene therapy and transplant-related drugs |
|
Andra E. Miller, Ph.D.
Senior Consultant |
Phone: 301-320-9537
E-Mail:  |
| Expertise in CMC, regulatory and GMP requirements for cell and gene therapy products |
|
Reginald D. Neal,
Senior Consultant |
Phone: 202-294-8543
E-Mail:  |
| Expertise in facility inspections, facility validation and regulatory requirements |
|
Daniel P. Offringa,
Consultant |
Phone: 703-739-5695
E-Mail:  |
| Expertise in electronic submissions |
|
Peter A. Patriarca, M.D.
Senior Clinical Consultant (with MD) |
Phone: 301-233-3220
E-Mail:  |
| Expertise in biological product development, clinical evaluation, and product lifecycle management |
|
David J. Pepperl, Ph.D.
Senior Consultant |
Phone: 301-987-5627
E-Mail:  |
| Expertise in nonclinical pharmacology and toxicology and preclinical development of biologic products |
|
Stuart Portnoy, M.D.
Senior Consultant (with MD) |
Phone: 703-466-0961
E-Mail:  |
| Expertise in developing successful regulatory strategies for medical devices across a wide range of therapies |
|
Peter Probst,
Vice President |
Phone: 301-831-3007
E-Mail:  |
| Expertise in GMP compliance; quality assurance; facility audits/inspections, facility validation & regulatory requirements; facility design evaluation |
|
Miriam C. Provost, Ph.D.
Senior Consultant |
Phone: 703-242-0459
E-Mail:  |
| Expertise in developing successful regulatory strategies for medical devices and combination products. |
|
Kelly Reich, M.S.
Associate |
Phone: 703-739-5695
E-Mail:  |
| Expertise in project management, regulatory submissions (paper and electronic) |
|
Stephen Rhodes, M.S.
Senior Consultant |
Phone: 301-579-3700
E-Mail:  |
| Expertise in developing successful regulatory strategies for medical devices and combination products |
|
Nadine M. Ritter, Ph.D.
Senior Consultant |
Phone: 240-372-4898
E-Mail:  |
| Expertise in analytical CMC technical and regulatory requirements and R&D/GLP/GMP laboratory quality practices for biotechnology products |
|
David Rouse, M.S.
Senior Consultant |
Phone: 919-303-1624
E-Mail:  |
| Expertise in research, review and regulation of biological products within CBER and the biopharm industry. |
|
Holly Scott,
Senior Consultant |
Phone: 407-435-3734
E-Mail:  |
| Expertise in inspections of FDA regulated industries including biologics & human tissue operations, clinical trial monitoring, and dietary supplements |
|
Jessica Shaw,
Administrative |
Phone: 703-739-5695
E-Mail:  |
|
|
Ann Sutton, MPH
Vice President |
Phone: 303-903-2097
E-Mail:  |
| Expertise in CMC, regulatory and product development for vaccines and live biotherapeutic products |
|
Carol Urps,
Administrative |
Phone: 703-739-5695
E-Mail:  |
|
|
Holli S. Vaughan, M.S., RAC
Associate |
Phone: 703-739-5695
E-Mail:  |
| Expertise in project management, regulatory submissions (paper and electronic), Orphan Drug Designations |
|
Michael S. Williams,
Vice President |
Phone: 703-216-7944
E-Mail:  |
| Expertise in regulatory and product development for viral products, specializing in all aspects relating to influenza virus vaccines |
|
Ben Wimmer,
Associate |
Phone: 703-739-5695
E-Mail:  |
| Electronic Publishing/IT/Web Maintenance |
|
Larry K. Winberry, Ph.D.
Senior Consultant |
Phone: 248-396-5818
E-Mail:  |
| Expertise in quality systems, manufacture and control, and product development for biological products |
|
William F. Winslow, PLLC
Chief Legal Officer |
Phone: 703-739-5695
E-Mail:  |
|
|
Ruth Wolff, Ph.D.
Senior Consultant |
Phone: 301-921-4160
E-Mail:  |
|
|
Anne M. Zurbay, RN, MSN, ND
Consultant |
Phone: 303-589-4813
E-Mail:  |
| Expertise in medical writing, clinical safety, product development, and in authoring the clinical sections of marketing applications |
|
|
|
West Coast Office
1840 Gateway Drive, Suite 200
San Mateo, California 94404
|
Tel (650) 378-1303
Fax (650) 378-1399 |
Biologics Consulting Group, Inc.- West Coast Office
San Mateo, California
BCG's West Coast Operations are now based in San Mateo, CA in the heart of the Biotech Bay area. The office is conveniently located close to San Francisco International Airport and is within easy driving distance to both the Oakland and San Jose airports. These headquarters make an ideal place for meeting with client companies. Services Offered by the West Coast Office include:
- Regulatory support and advice
- Regulatory submission development and compilation
- Regulation and policy development for cell and tissue-based therapy products
- Program management of biotech products
- Clinical development advice and assistance
- Quality Systems development and assessment
- Biologics manufacturing operations advice and support
- Identifying, qualifying, and managing contract manufacturing and testing organizations
- Quality Auditing
- Due diligence
|
West Coast Office Staff:
Craig Halverson,M.S.
Senior Consultant |
Phone: 206-491-4222
E-Mail:  |
| Expertise in developing successful quality and regulatory strategies for biopharmaceuticals |
|
Louise C. Johnson,M.S.
Senior Consultant |
Phone: 650-740-4750
E-Mail:  |
| Expertise in regulatory affairs for investigational and marketed small molecules and investigational biotechnology products |
|
Ronald A. Marchesani,
Office Head |
Phone: 650-378-1303
E-Mail:  |
| Expertise in compliance audits, facility design evaluation and quality system development/evaluation/oversight for biotechnology products |
|
Barbara J. Potts,Ph.D.
Senior Consultant |
Phone: 415-676-1792
E-Mail:  |
| Expertise in the science, compliance, & business aspects of control of adventitious agents. |
|
Rebecca Spence,Ph.D.
Consultant |
Phone: 720-854-4874
E-Mail:  |
| Expertise in evaluating clinical data and communicating science through clinical, regulatory, and commercial documents. |
|
Darin J. Weber,Ph.D.
Senior Consultant |
Phone: 206-940-3923
E-Mail:  |
| Expertise in regulatory strategy and CMC development for cell-based therapies and engineered tissues |
|
|
|
North Carolina Office
125 Edinburgh South Drive,
Cary, North Carolina 27511 |
Tel (919) 657-0435
Fax (919) 657-1737 |
Biologics Consulting Group, Inc. - North Carolina Office
Cary, North Carolina
Biologics Consulting Group, Inc.'s strategic NC location brings BCG in close contact with the biotech companies of Research Triangle Park and many notable Universities making advances in the biotechnology field. |
North Carolina Office Staff:
Angela Blackwell M.S.
Senior Consultant |
Phone: 704-450-9934
E-Mail: |
| Expertise in preclinical testing and biocompatibility of devices and combination products |
|
Mary Croucher
Administrative |
Phone: 919-657-0435
E-Mail: |
|
|
Thomas J. Gerteisen Ph.D.
Senior Consultant |
Phone: 919-264-7860
E-Mail: |
| Expertise in quality systems, process/product/materials specifications, test method qualification/validation, mock PAI audits, third party audits |
|
John E. Humphries M.D.
Senior Clinical Consultant (with MD) |
Phone: 919-960-3444
E-Mail: |
| Expertise in clinical strategy and clinical development of therapeutic proteins. |
|
Eugene B. Johnston CQE, CQA
Office Head |
Phone: 919-657-0435
E-Mail: |
| Expertise in quality management and regulatory compliance |
|
Ellen Raaf MT, ASCP
Senior Consultant |
Phone: 919-770-0633
E-Mail: |
| Expertise in assay development, validation, and stability while also optimizing Quality Systems and Trackwise® software implementation. |
|
|
|
New England Office
310 North Main Street,
Unit 6
Mansfield, Massachusetts 02048 |
Tel: (508) 541-8883
Fax: (508) 339-2307
|
Biologics Consulting Group, Inc. - New England Office
Mansfield, Massachusetts
With the opening of the Massachusetts office, BCG will continue to expand its ability to provide complete regulatory support to the biologics industry in New England and beyond. Services provided by the New England based BCG staff include:
- Regulatory advice and support
- Quality Systems development and assessment
- Biologics manufacturing operations advice and support
- Identifying, qualifying, and managing contract manufacturing and testing organizations
- Quality Auditing and Management Planning for Regulated Data and Computer Systems
- 21CFR Part 11 risk assessment and compliance advice
- Program management of biologic products
- Clinical development support and advice
- Advice and support for process development, validation, and process analytical technology (PAT)
- Due diligence
|
New England Office Staff:
Orest Hurko M.D.
Senior Clinical Consultant (with MD) |
Phone: 610-622-5000
E-Mail:  |
| Expertise in biomarker strategies for small and large molecule therapeutics. Clinical expertise in neurological and in mendelian disorders |
|
Jim McIver Ph.D.
Senior Consultant |
Phone: 781-718-5734
E-Mail:  |
| Expertise in product management, development, manufacture, control and regulatory submission for biological products and bioassays |
|
Bruce Pearce Ph.D.
Senior Consultant |
Phone:
E-Mail:  |
| Expertise in pharmacology/ toxicology, regulatory affairs, quality assurance, preclinical safety testing. |
|
Ronald A. Salerno Ph.D.
Senior Consultant |
Phone: 215-896-2067
E-Mail:  |
| Expertise in global regulatory strategy and registration for vaccines, biologics and drugs including application of pharmacogenomics and biomarkers for regulatory decision-making. |
|
Nanda K. Subbarao Ph.D.
Senior Consultant |
Phone: 609-937-5892
E-Mail:  |
| Expertise in analytical CMC technical and regulatory requirements and R&D/GLP/GMP laboratory quality practices for biotechnology and drug products. |
|
Michael A. Trapani MS, MBA
Senior Consultant |
Phone: 908-359-9519
E-Mail:  |
| Expertise in GCP, GLP and GMP audits, regulatory compliance and quality assurance/systems for biological and drug products |
|
Keith Wells Ph.D.
Office Head |
Phone: 508-541-8883
E-Mail:  |
| Expertise in biological product process development, validation, manufacturing and quality assurance |
|
|
|
BCG-Japan
Shinkawa KS Building 3F,2-22-6 ShinkawaChuo-ku
104-0033,Tokyo
|
Tel ++81-(0)3-6802-9230
Fax ++81-(0)3-3555-3717 |
|
|
