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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 teams

• 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 specifications

• 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


 

 



Meet our Partners:


Colin has 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 Hoerle
 
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.

Suzanne holds a Bachelor of Science in Chemistry degree from the University of Michigan.