Regulatory

ACIC REGULATORY AFFAIRS, QUALITY ASSURANCE, AND COMPLIANCE SERVICES

ACIC provides global regulatory affairs, quality assurance, and compliance services to both its supplier partners and customers. Such services include, but are not limited to:

• Preparation and review of Drug Master Files for submission to the U.S. FDA, Health Canada, and European Agencies; in both paper and eCTD format
• Acting as the U.S. and Canadian Agent for drug product submissions by foreign manufacturers
  Electronic Drug Establishment and Product Listing through U.S. FDA Electronic Submission Gateway (mandatory effective June 1, 2009) – DocuBridge
• Manufacturing Regulatory Compliance Audits, Gap and Risk Analysis
• Hands-on involvement in quality system development and implementation of systems and procedures to ensure compliance and successful regulatory agency inspection results
• GMP training and cultural transformation
• Active presence, if necessary, during customer and governmental agency inspections
• Technical and strategic support in responding to deficiency or inspectional observations letters
• Facility planning, design review, and equipment selection support
• Preparation and review of plant and equipment qualification master plans and protocols
• Preparation and review of process and cleaning validation protocols
• Technology transfer and strategic regulatory advice on change control, process changes, and site transfers
• Analytical method transfer and validation
• Aseptic Processing and Validation Program Evaluation