About

Brent Ristow is a scientific, legal, and regulatory expert with deep cross-disciplinary expertise in pharmaceutical and medical device development. With a PhD in Organic Chemistry and a JD focused on intellectual property and FDA compliance, Brent brings a rare blend of technical acumen and legal precision to every engagement. He has over a decade of experience designing and managing preclinical studies, auditing GMP and GLP processes, and ensuring regulatory compliance under 21 CFR Subchapters A, D, and H, USP, EP, ISO and ICH standards, and FDA statutes for ethical pharmaceuticals, medical devices (Class I–III), and combination products.

As a leader in the CRO/CDMO space, Brent has negotiated and drafted a wide range of commercial and quality agreements including Master Service Agreements (MSA), Master Quality Agreements (MQA), Confidential Disclosure Agreements (CDA), Standard Operating Procedures (SOPs), Statements of Work (SOWs), and Quotes. His strategic insights have driven cost optimization, intersite integration, and margin improvement at organizations like Pace Life Sciences, Solvias USA, and his own firm, Brighton Ashford LLC. Brent has also supported international expansion efforts and trained commercial teams to align technical capabilities with client needs.

With a passion for bridging science and business, Brent offers clients a comprehensive understanding of regulatory filings, technical study design, and contract structures that support successful product development. Whether advising on extractables and leachables testing, preparing Module 3 regulatory documentation, or integrating marketing with scientific reporting, Brent delivers trusted, high-impact solutions for complex regulatory and commercial challenges.