Syed Saleem, PharmD, MBA is a pharmacist, entrepreneur, and executive leader with over 25 years of experience in the U.S. pharmaceutical and life sciences sector. A graduate of the University of Oklahoma (Doctor of Pharmacy and MBA), he combines clinical training with business strategy to lead large-scale sterile pharmaceutical projects and enterprise operations. Dr. Saleem is licensed as a pharmacist in 25 U.S. states, demonstrating broad clinical and regulatory reach across multiple jurisdictions.

He has led the end-to-end delivery of multiple sterile pharmaceutical manufacturing facilities—from concept and facility design through construction, equipment procurement, calibration, validation and commissioning to full operational readiness. His operational remit has included aseptic filling and sterile process setup, clean operation workflows, vendor and supplier qualification, validation protocols (IQ/OQ/PQ), equipment qualification and calibration, SOP development, workforce training, and establishing release and stability testing programs to meet FDA, cGMP and international regulatory expectations.

On the regulatory side, Dr. Saleem has direct experience preparing and managing regulatory submissions, including Module 2 (Quality Summary) and Module 3 (CMC) dossiers, eCTD formatting and submission, and detailed interactions with regulatory agencies. He has overseen pharmacovigilance, post-market surveillance, CAPA implementation, and successful remediation of FDA Form 483 observations. His quality leadership spans both QA and QC functions—defining quality systems, managing inspections, and ensuring product compliance across 503A/503B compounding, sterile, and life sciences operations.

As an executive and entrepreneur, Dr. Saleem has been responsible for strategic planning, P&L oversight, budgeting, and corporate governance. He has applied technology solutions to operations—leading software development and systems implementation projects to automate batch records, compliance tracking, and quality workflows. His applied experience includes case-study collaborations with major industry players and technology leaders, and participation in professional forums such as the A4M World Congress (2024) and the Compounding Quality Center of Excellence Annual Conference (2022).

Beyond technical operations, Dr. Saleem mentors professionals and entrepreneurs as a life coach and advisor—helping teams translate regulatory constraints into commercially viable, innovation-driven products. His leadership philosophy emphasizes balancing regulatory excellence with entrepreneurial agility, building resilient operations through strong quality systems, and using technology to drive repeatable, auditable, and efficient manufacturing outcomes.