About Us

RegDev offers drug development services to pharmaceutical and biotech companies across the globe to support them through the entire drug development cycle. We help companies build robust Quality Management Systems and improve Regulatory Compliance across GXPs. Our expertise includes:

• Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)
• Good Pharmacovigilance Practice (GVP)
• Good Manufacturing Practice (GMP)
• Computer System Validation (CSV) and 21 CFR Part 11 Compliance
• Quality Management Systems (QMS)
• Clinical Operations
• Trial Master File (TMF)
• Gap Assessments
• Audits and Inspection Readiness
• Remediation
• Risk-Based Assessments
• Vendor Qualification and Management
• CAPA Support
• Drug Safety and Pharmacovigilance
• Training
• SOP Development and Training

Sid has an MBA from Pepperdine University and with this foundation, he has been able to successfully navigate the business world. Over the past 25 years, Sid has lead several global Quality and Compliance business units as an executive or as a senior consultant leading to approvals of key blockbuster drugs. The cumulative sales of these drugs has exceeded $100 billion annually over the last 20 years.

Sid specializes in helping companies pass compliance assessments, develop robust quality systems and prepare for FDA reviews and inspections. His leadership skills enable him to form cross-functional alliances for improvement and growth. His sensitivity to cultural nuances has helped him to succeed on a global scale. He has worked extensively in Russia, India, Poland, Ukraine, China, Japan, South Africa, and Australia to name a few.