Alok Naik

Managing Partner @Axentra Global Pharma Compliance Llc

Albuquerque, NM, US

As the Managing Director of Axentra, I specialize in eliminating regulatory risk for global manufacturers. I leverage my deep background in Pharmaceutical Regulatory Affairs to provide a superior standard of FDA compliance for the nutraceutical and biologics sectors.Key Responsibilities & Expertise:Official Correspondent & U.S. Agent: I serve as the FDA’s official contact, managing all Drug Establishment Registration, Listing (SPL), and annual renewal processes.FSVP & Quality Oversight: We develop and validate high-risk compliance programs (FSVP Plans, GMP Quality Systems) using a pharmaceutical-grade risk model.Strategic Submissions: Coordinate projects with our expert lead Regulatory Team for end-to-end regulatory strategy, advising clients on complex submissions (IND/NDA support) and managing all documentation for FDA clearance.Crisis Management: Direct the firm\'s rapid response to critical FDA enforcement actions, including Warning Letters, Import Detentions, and Form 483 inspection observations.Global Liaison: Manage international compliance projects, acting as the key regulatory bridge between foreign establishments and U.S. market requirements.I focus on delivering clear, audit-proof compliance so my clients can focus on innovation. Connect with me or visit AxentraCompliance.com.

Bharti vidyapeeth University

Bachelor of Pharmacy (B.Pharm.)

Nirma University , India

Bachelor of pharmacy hon's ( pharm d )

Poona College of Pharmacy, Pune

Bachelor's degree

Long Island University

Master of Science - MS