Shamim Chowdhury

Shamim Chowdhury is a senior regulatory consulting executive with more than 25 years of experience helping pharmaceutical, biologic, and medical device organizations strengthen quality systems, address complex compliance challenges, and execute risk-based GMP strategies. He advises clients across product development, manufacturing, quality systems, compliance, and regulatory strategy, with deep experience supporting high-stakes remediation and FDA enforcement response. Shamim has led and supported complex engagements involving Consent Decrees, Warning Letters, 483 responses, data integrity, GMP and QMSR audits, manufacturing facility assessments, pharmacy compounding operations, and multi-site quality system harmonization.

Work Experience 
Shamim brings extensive expertise in quality compliance, regulatory strategy, and operational remediation. He helps organizations design, improve, and harmonize quality and regulatory systems that support sustainable compliance and inspection readiness. His international experience includes client engagements across Europe, India, Asia-Pacific, and Puerto Rico, giving him a broad perspective on global regulatory expectations and quality system execution.

In addition to his technical and regulatory expertise, Shamim brings PMP-certified project management capability and experience in validation quality system design and redesign, enabling him to lead complex initiatives with discipline, structure, and measurable progress.

Education
Shamim earned his B.S. in Chemical Engineering from Illinois Institute of Technology and is pursuing an M.S. in Business Administration in Healthcare Management.