We understand the critical importance of pharmaceutical validation in the industry. Our pharmaceutical validation services are tailored to deliver distinct advantages to the manufacturers of pharmaceuticals and components. With in-depth knowledge of regulated process, equipment, Laboratory Qualification, Computerized System Validation (CSV), Global Computerized Systems, Engineering - Utilities Systems, Cleaning Validation and a deep understanding of the current Good Manufacturing Practices (cGMP) set by regulatory agencies; we offer a comprehensive suite of validation services to support your operations.
We can collaborate with corporate and/or site personnel to assess corporate and/or site business areas to confirm validation and/or qualification strategy and deliverables (i.eIQ, OQ and PQ), company SOP and Guidelines are aligned with Regulatory agency expectations. We offer qualification and/or validation services from Commissioning to Decommissioning phases. If any compliance finding is identified, Gintegra personnel can support to create a specific Validation Remediation Plan including CAPAs.
Our services cover qualification, validation, revalidation, and remediation activities, and periodic compliance review to confirm that your systems and facilities are in compliance and maintain the validated state. We deliver thorough validation documents, offering transparent and traceable evidence of validation outcomes.
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We are ready to connect and assist you with your regulatory compliance needs and challenges. Please provide us with the information requested and you will be on your way to a strong and sustainable regulatory compliance.
