Pharmazone specializes in USFDA Audit consulting, helping pharmaceutical, biotechnology, medical device, API, CMO, and CRO regulatory achievement.
Rs.380,060
Pharmazone helps pharmaceutical, biotechnology, API, medical device, CMO, and CRO organizations prepare for every USFDA Audit through comprehensive regulatory and quality consulting services. Our team performs independent mock USFDA inspections, GMP compliance evaluations, facility walkthroughs, documentation reviews, quality management system assessments, and data integrity audits to identify regulatory gaps before an official inspection. We also assist with CAPA development, root cause analysis, employee training, SOP optimization, and remediation activities to strengthen overall compliance. Headquartered in Ahmedabad, Gujarat, India, with international offices in Shanghai, the USA, Canada, and Europe, Pharmazone supports clients in more than 15 regulated markets.
Our additional expertise includes regulatory affairs consulting, GxP audits, GMP validation, pharmacovigilance services, dossier compilation, and supplier qualification audits. By combining industry expertise with a risk-based approach, Pharmazone enables organizations to improve inspection readiness, reduce compliance risks, and confidently achieve successful USFDA Audit outcomes.
Address: 402, Shafalya Elegance Nr. Shakti Arcade, Science City Road, Sola, Ahmedabad, Gujarat – 380060
Email: info@pharmazones.com
Phone: 96011 95652