Kelly Barhite, Founder & Owner, is a seasoned scientist and skillful consultant, having served in a breadth of roles at multiple companies over the last fifteen years.

Kelly’s extensive background and previous roles include:

• Proven and experienced manager of stability programs, release testing, analytical method development, transfer, and validation, including outsourcing

• Reliable author of regulatory filings

• Knowledgeable auditor for CDMO selection, data integrity, in-process audits, and inspection readiness

• Trusted and valued collaborator and contributor

• Dedicated and professional company representative reflecting its core values when liaising with CDMOs/CROs