Steve Pondell

Biography

Steve Pondell is a Principal at Integrated BioTech Solutions. He is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production. As an expert consultant, Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analyses, Phase I product development programs, cGMP compliance and supplier audits, and business development activities for a global logistics provider. He has experience at working with small biotech companies as well as multi-national pharmaceutical companies. He has served as a contract manufacturer and as a virtual manufacturing outsourcing manager. His particular specialty is assisting companies work across the sponsor/contract manufacturing relationship, creating high performing partnerships on a global basis. Steve earned his Chemical Engineering degree from the University of Michigan and his MBA from the Lake Forest Graduate School of Management.

Research Interest

"IBTS brought a team of professionals to the table, each with specific expertise, which supported and complemented our internal team. They provided an unbiased, external perspective when it came to reviewing systems, documentation, and providing guidance as part of an overall Gap Assessment to determine if we were ready for Agency inspection, product approval, and subsequent launch. This Gap Assessment highlighted areas of concern, and provided us with an opportunity to prioritize, and to focus our internal and external resources on addressing those key issues identified, to ensure success."