In Consulting Services

PharmaNet offers a comprehensive range of early- and late-phase consulting services on topics including: international regulatory affairs; scientific and medical affairs; quality; risk management; chemistry, manufacturing and controls; as well as biopharmaceutical investor issues.

Combination Products

The challenges involved in the development, manufacture, and regulation of combination products can be exponentially more difficult than those faced by the drug or device alone. PharmaNet Consulting professionals can assist in their development, having been involved in designing and conducting clinical trials for combination products; assisting with manufacturing issues; preparing and submitting marketing applications for these products; and helping to develop the approach taken by international regulatory agencies to combination product jurisdiction, regulation, and technical/clinical evaluation.

 

PharmaNet professionals available for consultation on this topic include:

 

Andrew Chang, PhD

Executive Director, PharmaNet Consulting


Bengt Danielsson, MD

Vice President, PharmaNet Consulting

 

William M. Egan, PhD

Executive Director, PharmaNet Consulting


Joyce Lea Frey-Vasconcells, PhD

Executive Director, PharmaNet Consulting


Gregory M. Hockel, MBA, PhD

Senior Vice President, Regulatory Affairs Worldwide


Mary F. Johnson, PhD

Executive Vice President, Biostatistics

 

Francois Xavier Lacasse, PhD

Director, Drug Development, Scientific and Regulatory Affairs, Anapharm


Stephane Lamouche, MSc, PhD

Project Manager, Drug Development, Scientific and Regulatory Affairs, Anapharm


Duu-Gong Wu, PhD

Executive Director, PharmaNet Consulting

 

PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390