Complete
Regulatory Support for the Biologics Industry |
 |
Biologics
Consulting Group, Inc.-
West Coast Office
1840 Gateway Drive
Suite 200
San Mateo, California 94404
P (650) 378-1303
F (650) 378-1399
|
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
The
West Coast consultants & their areas of expertise:
| Consultant |
Expertise |
Contact
information |
Ron
Marchesani
Head, West Coast Office |
compliance
audits, facility design evaluation and quality system development/evaluation/oversight
for biotechnology products |
P
(650) 378-1303
 |
Susan M. Bowley,
PhD
Senior Consultant |
mechanical and biomedical engineering
related to medical device testing and FDA regulatory submissions. |
P
(202) 538-4432
 |
Nebojsa
M. Djordjevic, Ph.D.
Senior Consultant |
Expertise
in development and implementation of analytical and bioanalytical
procedures specific to characterization of API and finished
dosage forms |
C
(650) 245 1745
 |
Louise
Johnson, MS
Senior Consultant |
regulatory
affairs for investigational and marketed small molecules and
investigational biotechnology products |
C
(650) 740-4750
 |
Gilbert T. Salud
Senior Consultant |
regulatory requirements for NDA/BLA/PMA/510K applications,
GMP and QSR compliance audits for pre and post market products. |
P
(408) 338-7381
 |
Ruth
E. Wager, PhD
Senior Consultant |
product development and characterization, quality
practices, and CMC regulatory requirements |
P
(805) 498-8191
 |
Darin
Weber, PhD
Senior Consultant |
regulatory
strategy and CMC development for cell-based therapies and engineered
tissues |
P
(206) 522-5600
 |
View the consultants' Areas of Expertise
Contact
Information for the West Coast Office:
Tel: (650) 378-1303
Fax: (650) 378-1399
Head
of West Coast Office - Ronald Marchesani
Biologics Consulting Group, Inc.
West Coast Operations
1840 Gateway Drive
Suite 200
San Mateo, California 94404
Page
Updated:
August 20, 2008
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