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.