Upgradation of Domestic Site to Regulatory

• GMP Audit
• GXP Audit
• Third Party / Vendor Audit
• Pre-Health Authorities Mock Audit
• Warning Letter Lifting
• Post Inspection Remediation
• Import Alert Lifting
• Quality Systems Development
• Computer System Validation
• Merger and Acquisition Consulting Services
• GMP Retainership on Hourly Basis
• Quality, GMP and Technical Trainings
• Engineering Services
• SOP Review and Writing
• Upgradation of Domestic Site to Regulatory

Upgrading a domestic site to meet regulatory standards involves a comprehensive process to ensure compliance with the regulations and standards set forth by regulatory authorities such as the US Food and Drug Administration (US FDA), the European Medicines Agency (EMA), etc. MASUU has vast experience in this field as it has inspectors who have worked in US FDA, MHRA, ANVISA earlier. Steps involved in upgradation of a domestic site to regulatory site are gap assessment, regulatory requirements analysis, action plan development, upgradation of infrastructure, implementation of QMS, Personnel training & Qualification, Documentation & Record keeping, Regulatory submissions, Audits and inspection preparation, continuous improvement, engagement with regulatory authorities, post upgrade monitoring and maintenance, etc. By following these steps and dedicating resources to upgrading the domestic site to regulatory standards, MASUU can ensure compliance with regulatory requirements, enhance product quality and safety, and maintain market access for clients’ products.