We can support our clients with:

• Quality System Assessment and Audits
• Supplier Qualification
• Technology Transfer Support
• Laboratory Quality Systems
• Preparation for Inspections and Remediation Programs
• Microbiology Process Assessments
• Validation Strategies and Documentation
• Company or Product Acquisitions (regulatory due diligence)
• Coordination of Regulatory Certificates
• Special Projects

As stated by FDA “FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.”

FDA also emphasizes that decisions regarding company's compliance with CGMP regulations are usually based upon inspection of the facilities and compliance history of the firm. At SCI we want to do our part to help you develop and maintain good compliance status, and help you minimize poor outcomes for your inspections. We can support our clients with:

• Review of Quality System effectiveness
• Auditing
• Remediation Programs