Mehul Patel

President

About

Quality Assurance and GxP Lead Auditor with 25+ years of global experience across Pharma, Biotech, Medical Devices, Clinical Research, and Digital Health. Expertise includes GCP/BIMO auditing, SaMD assessments, supplier quality oversight, and ISO‑based compliance (ISO 13485, 14971, 17025, 27001). Experienced with CRO, site, TMF, PV, and central lab audits, as well as software‑enabled medical technologies and AI‑supported tools. Known for strengthening quality systems, improving supplier performance, and supporting global regulatory readiness.

Country

United States

City

Greater Richmond Region

Industry

Pharmaceuticals

Skill

Drug Discovery, Data Analysis, Modeling, Stratification, Continuous Improvement, Artificial Intelligence (AI), Artificial Neural Networks, Biomarkers, Neural Networks, Readiness, Vendor Management, Quality Operations, Vendor Qualification, Supplier Quality, High Level Of Accuracy, Coaching, Cell Therapy, Investigation, GAMP, Business Process Improvement

Experience

President

smp Consulting, LLC

2010-10 - Present · 16 yrs

Richmond, VA

Founder & Principal Consultant, SMP Consulting LLC – Provide global consulting services for 40+ pharmaceutical, biotech, medical device, and consumer health organizations. Served in interim executive quality roles and led numerous inspection readiness, remediation, and compliance transformation initiatives.

Data Quality Manager

Altria

2018-9 - 2020-2 · 1 yr 6 mos

Richmond, Virginia, United States

Directed contract lab oversight, vendor qualification, and data integrity for GLP/GCP/ISO compliance.

Director of Quality Systems

NSF - Life Sciences

2017-3 - 2018-2 · 1 yr

Washington DC-Baltimore Area

Built and managed regulatory consultancy and training practice; conducted audits across APIs, finished dosage, packaging, CROs, medical devices, and food.

Regulatory and Compliance Specialist/ Product Management

Boehringer Ingelheim

2006-10 - 2010-10 · 4 yrs 1 mo

Petersburg, Virginia, United States

Supported CMC submissions, inspection readiness, and liaison with FDA/EMA. Quality Oversight of batch release for Controlled and Narcotic (DEA controlled) APIs

Quality Assurance Team Lead

ALMAC CLINICAL SERVICES LIMITED

2005-8 - 2006-10 · 1 yr 3 mos

Audubon, Pennsylvania, United States

Directed batch review, audits, and GMP training programs. Quality Oversight of the Blinded and Double Blinded clinical trial Kit packaging.

Quality Assurance and Quality Control Officer

SUN PHARMA

2000-2 - 2003-2 · 3 yrs 1 mo

India

Oversaw QA operations including product disposition, APRs, validation, and regulatory audits.

R&D and Product Development Officer

Sidmak Laboratories (I) Pvt. Ltd.

1999-3 - 2000-2 · 1 yr

India

R&D Officer: Supported development of new products and dosage forms

Education

Rajiv Gandhi University of Health Sciences

Pharmacy

1996 - 2000 · 4 yrs

MIT Sloan School of Management

Artificial Intelligence

The landscape of artificial intelligence (AI) in the pharmaceutical industry. Using AI for early drug discovery: From small molecules to biologics. Modeling the biological underpinning of disease. Biomarkers, discovery, and patient stratification. Design and Management of Clinical Trials. Business Innovation in Pharma.