Complete Regulatory Support for the Biologics Industry
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Main Office
1317 King Street
Alexandria, Virginia 22314
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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.
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Main Office Staff:
Kerin Ablashi, M.S.
Consultant |
Phone: 240-888-9118
E-Mail:  |
| Expertise in project management, regulatory submissions |
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Ellen M. Areman, MS, SBB
Senior Consultant |
Phone: 410-207-0531
E-Mail:  |
| Expertise in development of cellular biological products, especially hematopoietic, immunologic and stem cell therapies |
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Julia Barrett, M.D., MPH
Senior Clinical Consultant (with MD) |
Phone: 303-679-6214
E-Mail:  |
| clinical product development, clinical trial design and execution, FDA licensure requirements, and medical monitoring |
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Kelly T. Boyle,
Vice President |
Phone: 703-739-5695
E-Mail:  |
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Wilson W. Bryan, M.D.
Senior Clinical Consultant (with MD) |
Phone: 301-767-5034
E-Mail:  |
| Expertise in clinical development of drugs and biologics to treat neurological disorders |
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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 |
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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 |
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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 |
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James G. Kenimer, Ph.D.
President/CEO |
Phone: 703-739-5695
E-Mail:  |
| Expertise in regulatory strategy – FDA liaison |
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Steven C. Kunder, Ph.D., DABT
Senior Consultant |
Phone: 240-750-5035
E-Mail:  |
| Expertise in nonclinical pharmacology-toxicology and development for drugs, vaccines and biologic products. |
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David T. Lin, Ph.D., MBA
Senior Consultant |
Phone: 301-299-2853
E-Mail:  |
| Expertise in CMC (quality), product development, and FDA submission requirements |
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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 |
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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 |
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Reginald D. Neal,
Senior Consultant |
Phone: 202-294-8543
E-Mail:  |
| Expertise in facility inspections, facility validation and regulatory requirements |
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Daniel P. Offringa,
Consultant |
Phone: 703-739-5695
E-Mail:  |
| Expertise in electronic submissions |
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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 |
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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 |
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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 |
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Peter Probst,
Senior Consultant |
Phone: 301-831-3007
E-Mail:  |
| Expertise in GMP compliance; quality assurance; facility audits/inspections, facility validation & regulatory requirements; facility design evaluation |
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Kelly Reich, M.S.
Associate |
Phone: 703-739-5695
E-Mail:  |
| Expertise in project management, regulatory submissions (paper and electronic) |
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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 |
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Melissa Saathoff,
Administrative |
Phone: 703-739-5695
E-Mail:  |
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Jessi Shaw,
Administrative |
Phone: 703-739-5695
E-Mail:  |
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Ann Sutton, MPH
Vice President |
Phone: 303-903-2097
E-Mail:  |
| Expertise in CMC, regulatory and product development for vaccines and live biotherapeutic products |
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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 |
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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 |
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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 |
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William F. Winslow,
Chief Legal Officer |
Phone: 703-739-5695
E-Mail:  |
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Ruth Wolff, Ph.D.
Senior Consultant |
Phone: 301-921-4160
E-Mail:  |
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Lei Zhang, M.D., Ph.D.
Office Head |
Phone: 86 134 3916
E-Mail:  |
| Expertise in biologics product development |
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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 |
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West Coast Office
1840 Gateway Drive, Suite 200
San Mateo, California 94404
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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
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West Coast Office Staff:
Susan M. Bowley ,Ph.D.
Senior Consultant |
Phone: 408-738-8876
E-Mail:  |
| Expertise in mechanical and biomedical engineering related to medical device testing and FDA regulatory submissions. |
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Nebojsa (Micki) Djordjevic ,Ph.D.
Senior Consultant |
Phone: 650-245-8307
E-Mail:  |
| Expertise in development and implementation of analytical and bioanalytical procedures specific to characterization of API and finished dosage forms |
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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 |
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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 |
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Gilbert T. Salud ,M.S.
Senior Consultant |
Phone: 408-338-7381
E-Mail:  |
| regulatory requirements for NDA/BLA/PMA/510K applications, GMP and QSR compliance audits for pre and post market products. |
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Ruth E. Wager ,Ph.D.
Senior Consultant |
Phone: 805-750-0963
E-Mail:  |
| Expertise in product development and characterization, quality practices, and CMC regulatory requirements |
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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 |
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North Carolina Office
5001 Weston Parkway,
Suite 200A
Cary, North Carolina 27513 |
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:
Lourdes Bermejo M.S.
Senior Consultant |
Phone: 919-414-6831
E-Mail: |
| Expertise in project management for technology transfers and start-ups, manufacturing for biological products, process improvements upstream development & scale-up. |
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Angela Blackwell M.S.
Senior Consultant |
Phone: 704-450-9934
E-Mail: |
| Expertise in preclinical testing and biocompatibility of devices and combination products |
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Mary Croucher
Administrative |
Phone: 919-657-0435
E-Mail: |
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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 |
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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. |
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Eugene B. Johnston CQE, CQA
Office Head |
Phone: 919-657-0435
E-Mail: |
| Expertise in quality management and regulatory compliance |
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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. |
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New England Office
310 North Main Street,
Unit 6
Mansfield, Massachusetts 02048 |
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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
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New England Office Staff:
Loriann N.Baranauskas
Senior Consultant |
Phone: 774-573-1223
E-Mail:  |
| Expertise in quality systems, cGMP compliance practices and regulatory requirements for biotechnology products. |
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JimMcIverPh.D.
Senior Consultant |
Phone: 781-718-5734
E-Mail:  |
| Expertise in product management, development, manufacture, control and regulatory submission for biological products and bioassays |
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Ronald A.SalernoPh.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. |
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Nanda K.SubbaraoPh.D.
Senior Consultant |
Phone: 609-937-5892
E-Mail:  |
| Expertise in analytical CMC technical and regulatory requirements and R&D/commercial GLP/GMP quality systems for drugs and nutraceuticals |
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Michael A.TrapaniMS, 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 |
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KeithWellsPh.D.
Office Head |
Phone: 508-541-8883
E-Mail:  |
| Expertise in biological product process development, validation, manufacturing and quality assurance |
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China Office
5/F China Life Tower, 16, Chao Wai Street
Chaoyang District, Beijing,
100020 China
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Tel +86 10 5877 1111
Fax +86 10 5877 1222
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Biologics Consulting Group, Inc. - China Office
Chaoyang District, Beijing, China
With the opening of the Beijing office, BCG will continue to expand its ability to provide complete regulatory support to the biologics industry in China and beyond.
Lei Zhang, M.D. Ph.D. - Masterclass: Overview of FDA Regulations Relevant to Chinese Biomanufacturers
| December 13 - 14, 2007 |
IBC China |
US FDA Biological Approval Process |
Lei Zhang, MD, Ph.D.
(speaker) |
Beijing, China |
| January 14 - 15, 2008 |
IBC China |
US FDA Biological Approval Process |
Lei Zhang, MD, Ph.D.
(speaker) |
Seoul, South Korea |
| January 17 - 18, 2008 |
IBC China |
US FDA Biological Approval Process |
Lei Zhang, MD, Ph.D.
(speaker) |
Taipei, Taiwan |
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BCG-Japan
Shinkawa KS Building 3F,2-22-6 ShinkawaChuo-ku
104-0033,Tokyo
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Tel ++81-(0)3-6802-9230
Fax ++81-(0)3-3555-3717 |
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