Biologics Consulting Group, Inc. - New England

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

Staff

Consultant	Expertise	Contact information
Keith H. Wells, Ph.D. Head, North Carolina Office	biological product process development, validation, manufacturing and quality assurance	P (508) 541-8883
Loriann Baranauskas Senior Consultant	quality systems, cGMP compliance practices and regulatory requirements for biotechnology products.	C (774) 573-1223
Jim McIver, Ph.D. Senior Consultant	product management, development, manufacture, control and regulatory submission for biological products and bioassays	C (781) 718-5734
Ron Salerno, Ph.D. Senior Consultant	global regulatory strategy and registration for vaccines, biologics and drugs including application of pharmacogenomics and biomarkers for regulatory decision-making.	C (215) 896-2067
Nanda K. Subbarao, Ph.D. Senior Consultant.	analytical CMC technical and regulatory requirements and R&D/commercial GLP/GMP quality systems for drugs and nutraceuticals	C (609) 937-5892
Michael A. Trapani, MS, MBA Senior Consultant	regulatory affairs, regulatory compliance and quality assurance for biological and drug products	C (908) 359-9519

For further information regarding the New England BCG office, please contact Dr. Keith Wells.

View the consultants' Areas of Expertise

Contact Information for the New England Office:

Tel: 508-541-8883

Contact: Dr. Keith Wells

Biologics Consulting Group, Inc.
Massachusetts Office
310 North Main Street
Unit 6
Mansfield, MA 02048

Page Updated: June 12, 2008