Regulatory Support Services -

Regulatory Support Services

At ACIC, we provide comprehensive regulatory affairs, quality assurance, and compliance services to ensure seamless market entry and ongoing compliance for our customers and supplier partners. We understand that regulations are constantly changing, and our trusted global network helps you navigate complex regulatory processes while maintaining the highest standards of safety, quality and efficiency. Our customized solutions support every stage of development, ensuring your innovative products meet all the necessary requirements for a faster, safer path to market.

Partner with ACIC to accelerate your path to success. Contact us today to explore how our expertise, innovation, and global network can support your next breakthrough.

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:

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

from Molecule to Market with Innovation

Regulatory Support Services

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