ACIC Pharmaceutical Machinery also provides global regulatory affairs, quality assurance and compliance services to both its partners and customers. These capabilities are particularly useful when we act as master suppliers for turn-key projects and/or become engaged with our customers from the early stages.

Some of these services include, but are not limited to:

  • Facility planning, design review, and equipment selection support
  • Preparation and review of plant and equipment qualification master plans and protocols
  • Aseptic Processing and Validation Program Evaluation
  • Manufacturing Regulatory Compliance Audits, Gap and Risk Analysis
  • Hands-on involvement in quality system development, implementation of systems and procedures to ensure compliance
    and successful regulatory agency inspection results
  • 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
  • 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)
  • GMP training and cultural transformation
  • Active presence, if necessary, during customer and governmental agency inspections