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.

Research Interest

Pharmaceutical Products & Biotechnology