Our partners have a combined total of 46 years of experience in the pharmaceutical industry, including:
30+ years providing regulatory guidance to pharmaceutical development teams and preparing global CMC documentation for both
human and animal health drug applications
• 30+ years participation on regulatory affairs project
• Experienced in all phases of document preparation, including INDs, CTAs, NDAs, ANDAs, NADAs,
MAAs, and rest-of-world submissions, including post-approval support
• Extensive experience using
the Common Technical Document (CTD) format
• 30+ years establishing drug substance and drug product
• 5+ years cGMP/GLP/DEA compliance assurance
10+ years experience in analytical methods development
• Understanding of CMC and cGMP regulatory requirements
for biopharmaceuticals and biologics
over 28 years of experience in the pharmaceutical industry, primarily in regulatory affairs and project management. He
began his career in Kalamazoo, Michigan at The Upjohn Company, where he remained employed with Pharmacia and Upjohn, Pharmacia
Corporation, and Pfizer, Inc. After working in analytical methods development, then developing and
managing a cGMP compliance program, Colin joined the CMC regulatory affairs group at Pharmacia. As a principal
scientist Colin was responsible for providing regulatory CMC strategy and project management, and for preparing
the registration documentation for new human health compounds for all phases of drug development. With increasing expertise
in regulatory affairs, his level of responsibilities increased to include positions as a pharmaceutical development team leader
and as a regulatory CMC group leader. In his subsequent position as director of CMC regulatory affairs,
Colin managed regulatory scientists in the preparation of CMC registration documentation, participated on global development
teams, and spearheaded various initiatives for improving organizational performance and global quality standards. After
leaving Pfizer, Inc. in 2005, he gained additional experience in the generic pharmaceutical industry working as an associate director of
regulatory affairs for Hospira, Inc. and The Perrigo Co. Colin recently completed a cfpie training course entitled "CMC
Regulatory Compliance for Biopharmaceuticals & Biologics" in May 2008.
Colin holds a Bachelor of
Science degree in Chemistry from Miami University.
Suzanne has over 20 years of experience in the pharmaceutical industry.
She began her work in Kalamazoo, Michigan at The Upjohn Co., where she remained employed with Pharmacia and Upjohn,
Pharmacia Corporation, and Pfizer, Inc. until leaving in 2005 to utilize her regulatory affairs expertise in consulting.
After beginning her career in control laboratory operations and analytical methods development at The Upjohn
Co., she joined the consumer products group, where she was responsible for analytical methods development, project management,
and CMC regulatory strategy and documentation for over-the-counter human health products. She then took a position
in the CMC regulatory group at Pharmacia, where she gained considerable experience in animal health regulatory
affairs managing projects and preparing CMC documentation for animal health registrations in the US, Europe, and
other markets. Her 14 years of experience in regulatory affairs also include human health clinical
trial and market applications, management of a global CTD template change control team, and participation in process
improvement teams and regulatory affairs infrastructure initiatives. Suzanne recently completed a cfpie training
course entitled "CMC Regulatory Compliance for Biopharmaceuticals & Biologics" in May 2008.
a Bachelor of Science in Chemistry degree from the University of Michigan.