|
| "Effective Auditing of CMOs," Supplement to BioPharm International (Apr. 2010) Dr. L. Winberry |
| "The Combination Product Problem," RA Focus magazine (RAPS), (June 2009) Dr. Michael Gross |
| "Combination Product Terminology," RA Focus magazine (RAPS), (Aug. 2009) Dr. Michael Gross |
| "Structuring Combination Product Marketing Applications," RA Focus magazine (RAPS), (Sept. 2009) Dr. Michael Gross |
| "Combination Product Labeling," RA Focus magazine (RAPS), (Oct. 2009) Dr. Michael Gross |
| "Combination Product Quality Systems," RA Focus magazine (RAPS), (Dec. 2009) Dr. Michael Gross |
| "Postmarket Safety Reports for Combination Products," RA Focus magazine (RAPS), (Jan 2010) Dr. Michael Gross |
| "Reporting Manufacturing and Design Changes to Combination Product Marketing Applications" RA Focus magazine (RAPS), (Feb 2010) Dr. Michael Gross |
| "FDA Issues Draft Guidance on Injectors," RA Focus magazine (RAPS), (July 2009) Dr. Michael Gross |
| "Product Development of Probiotics as Biological Drugs," Chicago Journals - Clinical Infectious Diseases 2008; 46:S128-32 Ann Sutton |
| "Complying with FDA Quality Regulations for Development and Manufacture of Prefilled Drug Delivery Devices," RA Focus magazine (RAPS), (Oct. 2007) Dr. Michael Gross |
“Analytical
Test Methods for Biological and Biotechnological Products,” Dr. Nadine Ritter and J. McEntire, in Process
Validation in Manufacturing of Biopharmaceuticals: Guidelines,
Current Practices, and Industrial Case Studies (A.S.
Rathore and G. Sofer, eds), CRC Press, Taylor and Francis Group,
Boca Raton, FL, 2005, pp. 227-326. |
"Accelerated
Approval and Tougher Post Marketing Regulations: A Change in
the Playing Field" Journal of GXP Compliance. January
2005 Vol. 3, No. 2 - By Dr. Steve Litwin,
BCG Senior Clinical Consultant |
| FDA
Regulatory Affairs: A Guide for Prescription Drugs, Medical
Devices, and Biologics. Book Chapter on Biologics by Dr. Jim Kenimer, BCG President/CEO & Dr. John Jessop, BCG Director of Pharmacology/Toxicology |
| Gene
Transfer for Neurologic Disease: Agencies, Policy, and Process. Article in Neurology (Dec. 2004) by Dr. Andra Miller, BCG Director of Cell & Gene Therapies & Dr. Jerry Mendell |
| "The
IND (Investigational New Drug) Application: Is Our Product Safe
to Administer in the Clinic?" by Dr.
John Jessop, Director, Pharmacology/Toxicology with BCG (First published in GOR Volume 5 No 2 May 2003.
Reproduced by permission of Global Outsourcing Review."
Click on title above to read article.) |
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