Regulatory Strategies and Solutions, Inc.
Regulatory Strategies and Solutions, Inc.
Consultants

 

Deb Stolt has spent the past seventeen years working in the pharmaceutical and biotechnology industries supporting Supply Chain, Quality Assurance and Manufacturing areas.   Her excellent interpersonal skills, hands-on approach to problem-solving along with her attention to detail make her an ideal consultant to lead supply chain, manufacturing, and quality assurance activities.  In supporting supply chain activities, Deb understands sourcing requirements and supply chain models to apply the right system to meet the end user requirements.  She has knowledge of federal regulations as they apply to investigational and commercial pharmaceutical products being manufactured tested and marketed.  Her in depth experience in supplier auditing and quality assurance will satisfy clients with complicated and unique requirements.  Deb's experience in manufacturing (clinical and commercial) antibodies and small molecules leverages her ability work in a face-paced environment.  She has a collaborative spirit working across functions and can deal effectively with complex and diverse issues.  She has the ability to apply alternative and unique solutions to undefined and non-standard customers requests or requirements.   Deb has a Bachelor of Science degree from the University of Minnesota, Duluth.  Please contact Deb at deb@regstrategies.com.

 

Nancy J. Teasdale, RAC, has over twenty years of experience working in biotechnology, pharmaceutical and medical device industries in regulatory affairs supporting activities for investigational and commercial product development.  This experience includes working in firms of various sizes from start up to multinational.  Nancy has managed regulatory submissions for early stage development programs through commercialization. Additionally, she has been responsible for the preparation of multiple Investigational and New Drug Applications, pre-approval/post-marketing regulatory compliance activities, along with Investigational Device Exemption submissions, formal meeting requests to FDA and the associated briefing packages.  Her therapeutic experience includes working in oncology, cardiology, gastroenterology, central and nervous system, reproductive and urology, and dermatology drug product areas.  She has been involved in working with the Drug Enforcement Agency (DEA) in handling manufacturing, shipment and storage of both schedule one and three, drugs.  She is regulatory affairs certified (RAC) and received her Bachelor of Science degree from Iowa State University, Ames, Iowa.  Please contact Nancy at nancy@regstrategies.com.

 

 

 

Nancy J. Teasdale
4517 Sedum Lane
Suite 101
Edina, MN  55435

612-237-1026

www.regstrategies.com 

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