An effective Quality Management System (QMS) is crucial for Marketing Authorization Holders (MAHs) to successfully navigate unannounced and rigorous regulatory inspections. As clinical development and pharmacovigilance (PV) become increasingly complex, and regulatory requirements from various health authorities continually evolve, maintaining a compliant QMS is vital. MAHs must implement a robust audit program and adhere to routine QMS activities to ensure compliance.

SentinelRX offers efficient Quality Assurance (QA) services designed to meet regulatory requirements and industry standards, ensuring the safe and effective use of medicinal products. With a team of trained and experienced quality auditors specializing in PV and clinical domains, SentinelRX provides expert support and always maintains an inspection-ready environment.