CalCog Expands Controlled Substance Handling Capabilities to Include Cold Chain Storage and Transport Solutions
Caligor Opco, LLC (“Caligor Coghlan” or “CalCog”), a global expert in clinical supply services, is further enhancing its controlled substance handling capabilities by adding cold chain storage and transport solutions for Schedule I through V products. The expansion comes as a response to the increasing demand for cold chain storage solutions.
“We are seeing an increase in controlled substances being utilized as IMP in clinical trials,” said Darian Cross, Global Head of Operations. “These trials present unique complexities that require a specialized approach to ensure Drug Enforcement Administration (DEA) compliance.”
CalCog recognizes the significant complexities faced in controlled substance clinical trials including:
- Secure Storage and Chain of Custody: CalCog leverages its extensive experience to establish secure storage and transportation protocols specifically designed for controlled substances. CalCog’s controlled substance management offering includes import, ambient and refrigerated storage, secondary packaging, distribution, export, and destruction management. CalCog’s cGMP facility in Texas is equipped with advanced security measures including a 576 square foot DEA-compliant vault with restricted access, surveillance systems, and monitored / controlled temperature environments.
- Regulatory Compliance: With a deep understanding of the complex DEA regulatory landscape, CalCog provides expertise in navigating the stringent clinical supply regulations associated with depot storage and distribution of controlled substances.
- Documentation and Reporting: CalCog ensures accurate record keeping, documentation, and reporting to meet regulatory requirements, including controlled substance dispensation records and maintaining compliance with cGMP and GDP guidelines.
CalCog collaborates closely with our clients to develop customized controlled substance supply chain strategies that align with the unique needs of their clinical trials. These strategies optimize efficiency while maintaining the highest standards of safety and compliance.
For more information about CalCog’s specialized clinical supply management for controlled substances and its comprehensive range of clinical supply chain solutions, please visit calcog.com or contact us at [email protected].
About Caligor Coghlan:
CalCog is a global expert in clinical supply services, providing clinical packaging and labeling services, kit and label design services, global warehousing and distribution, comparator and commercial drug sourcing, and expanded access program management services for more than 27 years. With the infrastructure, expertise, and quality management systems of a large clinical supply company and the flexible production schedules and client responsiveness of a small company, CalCog is a key resource for small- and medium-sized pharmaceutical and biotech organizations, contract research organizations, and academic institutions. For more information about CalCog and its comprehensive service offering, please visit calcog.com.
Chief Business Officer