Regulatory Filing Solutions

01/10

Reviewing existing documentation on the cold chain, drug product stability, and packaging qualifications

02/10

Developing a validation master plan that outlines a risk mitigation strategy and execution plan, including transport validation and cold chain optimization

03/10

Mapping the entire supply chain and creating a detailed process flow diagram

04/10

Conducting risk and gap assessments using our proprietary Hazard and Operability (HAZOP) study

05/10

Recommending allowable acceptance criteria for drug product quality and thermal packaging qualification

06/10

Preparing detailed requirements for cold chain process controls and monitoring

07/10

Designing and executing transport simulation testing at our Advantage Transport Simulation lab, for raw materials, drug substances, intermediate and pre-cursors, and bulk and final drug products

08/10

Developing validation summary reports that confirm readiness to file for the cold chain and support completion of appropriate sections of the Chemistry, Manufacturing and Controls (CMC) in the Common Technical Document (CTD)

09/10

Preparing stakeholders for pre-approval inspections, by conducting mock audits and providing essential training

10/10

Reviewing and responding to regulators’ cold chain Information Requests or informal communication in a timely manner—improving the odds of a successful filing, keeping accelerated approvals moving, and maintaining future operational flexibility