Robert J. Wherry

• 43 years of international pharmaceutical, biotechnology & medical device experience
• Expertise in AI/ML Compliance, Quality Systems, Design Control, Computerized System Validation, Data Integrity Audits & Remediation, Quality Systems, Process Validation, Aseptic Processing, Regulatory Operations & eCTD submissions.
• BSc Chemical Engineering (Lehigh University)
• MSc Pharmaceutical Quality (University of Strathclyde)
• MS Regulatory Affairs (Northeastern University)
• Bob has also studied artificial intelligence and machine learning at MIT.
• Bob proudly serves as a New Hampshire State Representative.

Bob provides compliance consulting services including compliance approaches for artificial intelligence and machine learning, quality system design, gap assessments, mock inspection audits, vendor audits, data integrity assessments & remediation, computer validation, GxP compliance assessments and training, process development and process validation, CMC & Module 3 assessments, regulatory strategies, and leadership mentoring.