Quality Assurance/Quality Control Support

Regulatory Compliance Consulting

  • Expert guidance on FDA regulations and global quality standards. Support for navigating GMP and other compliance requirements.</

Quality Management System (QMS) Development

  • Design and implementation of a customized QMS. Documentation control and risk management processes.

Audit & Inspection Support

  • Preparation for FDA and third-party audits. On-site support during inspections and audits.

Training & SOP Development

  • Creation and delivery of training programs for QA/QC teams. Development of Standard Operating Procedures (SOPs) for compliance.

Quality Control Testing & Validation

  • Development of testing protocols for raw materials, in-process materials, and finished products. Stability testing and validation services.

Corrective and Preventive Action (CAPA) Support

  • Implementation of CAPA systems for non-conformance management. Root cause analysis and corrective action planning.

Supplier Qualification & Auditing

  • Vendor qualification, audits, and ongoing supplier monitoring. Ensuring GMP compliance across the supply chain.

Change Control Management

  • Development and implementation of change control procedures. Risk assessment and documentation for process changes.

Regulatory Documentation Support

  • Preparation and submission of regulatory documents. Management of compliance records and regulatory filings.

Ongoing Compliance Monitoring

    • Continuous tracking of regulatory updates and industry standards. Quarterly audits to ensure ongoing compliance.
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