Regulatory Compliance Services

Cryopak’s Regulatory Compliance business unit was created to help life sciences and health care companies meet the increasing regulatory standards and guidelines that the industry is facing today. This division not only Cryopak helps our customers meet the increasing regulatory compliance but also helps to reduce the cost of getting their products to market, as well as reduce overhead costs. The products and services that are offered by our Compliance Systems division provide compliance solutions to the following standards and guidelines:

• PDA TR 39 & 52
  U.S. Pharmacopeia (USP) 1079, Good Storage & Shipping Practices
  USP 1083 Good Distribution Practices-Supply Chain Integrity
  WHO drug stability standards
  ICH drug stability standards
  FDA cGMP framework

These increasingly strict standards and guidelines demand extensive knowledge and require a large service offering to fully comply. Cryopak has extensive knowledge and understanding of these standards and in turn created a diverse product and service offering to meet the needs of cold chain supply. Services that this division offers include:

Package Design and Qualification
Thermal Modeling and Simulation
Temperature Profile Mapping
Package Performance Modeling and Testing