Nexgen Pharma Solutions

NexGen Pharma Solutions is a global pharmaceutical GMP compliance and regulatory consulting firm dedicated to helping organizations achieve excellence in quality, regulatory compliance, and inspection readiness. Headquartered in Vadodara, Gujarat, India, we provide comprehensive solutions across GMP Audits, Regulatory Affairs, Quality Management Systems (QMS), Process Validation, Data Integrity, and Pharmaceutical Training. Our team of seasoned auditors and subject matter experts bring decades of combined experience in USFDA, EU GMP, MHRA, WHO GMP, and PIC/S environments, serving clients across India, China, and other emerging markets. We support formulation, API, and packaging facilities in building robust quality systems aligned with 21 CFR Parts 210/211, ICH Q7, ICH Q9, and ICH Q10. Through detailed audits, risk-based assessments, and hands-on remediation, we ensure our partners meet global regulatory expectations and sustain continuous improvement. Our Core Services Include: • Third-Party GMP Audits (India & International) • Regulatory Compliance & Inspection Readiness • Quality Management System (QMS) Implementation • Process, Cleaning & Media Fill Validation • Technology Transfer & Documentation Control • CAPA / Deviation / OOS / OOT Management • Data Integrity and 21 CFR Part 11 Compliance • Pharma Training & Regulatory Support At NexGen, we believe in Redefining Pharmaceutical Excellence by combining regulatory intelligence with practical on-site implementation. Our mission is to empower companies to operate ethically, efficiently, and in full compliance with global standards. Visit us: Contact: info@nexgenpharmasolutions.com