When shipping perishable products, such as food and pharmaceuticals, adhering to industry guidance, regulations, and accreditations are critical to ensuring safety and compliance. Our accomplished advisors specialize in industry-specific expertise, offering a comprehensive approach to meet your unique needs. By choosing Illuminate, you’re not just ensuring compliance; you’re securing the credibility and success of your organization in a complex landscape.
Cold Chain Regulatory Services
Omnichannel/Delivery Subject Matter Expert:
Engaging in strategic collaboration with client teams, providing support in operations and regulatory interpretation pertaining to delivery models, automation, shared services, and temperature-related delivery. Specializing as a subject matter expert in temperature shipping and offer consultation services for the implementation of temperature testing results, compliance with regulatory and accreditation requirements, and achievement of operational goals.
Testing ideas and sharing concepts with Boards through established relationships, while also coordinating efforts with pharmacy stakeholders when necessary. Focusing on maintaining positive relationships with boards of pharmacy, engaging in proactive and collaborative advocacy, and being involved in necessary messaging which is essential for board promulgation and pharmacy advocacy activities. Serving as a third-party representative by actively participating in external workgroups and meetings provides valuable insights and acts as the eyes and ears for the organization.
Accreditation & Inspection:
Engaging in strategic collaboration with client teams to provide support for licensing, inspections, and accreditations. This includes expertise in Healthcare Merchant Accreditation, Digital Pharmacy Accreditation, as well as managing VPP inspections and State Board inspections, and working closely with client teams to navigate and ensure compliance with these regulatory processes and standards.
Proactively monitoring pending legislation and regulations, with a focus on aspects such as multi-state/nonresident pharmacy practice, pharmacy fulfillment, licensure, accreditations, and pharmacy operations. Staying ahead of developments in these areas and providing clients with specific regulatory updates tailored to their needs ensures that clients are well-informed about the evolving regulatory landscape and can make informed decisions in accordance with the latest industry changes.
Board of Pharmacy Meeting Monitoring:
Systematically monitoring board of pharmacy meetings, focusing particularly on states where the client maintains a physical pharmacy presence and has key business partnerships. This involves reviewing meeting agendas, monitoring meeting minutes, and delivering comprehensive meeting reports to the client as needed or requested. Additionally, offering client-specific regulatory updates derived from the insights gained through the monitoring process ensures that the client remains well-informed about any pertinent developments discussed in these meetings.
Accreditation and Certification in Cold Chain
Our experts are active participants in leading new industry guidance and regulations. We can help you navigate the ever-changing industry landscape to ensure your shipments meet the latest rules for testing, qualification, thermal maintenance, and pharmacy law, practice, and operations. For the cold chain mail shipment of pharmaceuticals, accreditation and certification from recognized bodies are crucial to ensure compliance with industry standards and regulatory requirements. These accreditations and standards are pivotal in maintaining integrity and credibility.
International Safe Transit Association (ISTA)
As member of the International Safe Transit Association (ISTA) Thermal Blanket Task Force and Chair of the ISTA 7E Committee we have been instrumental in creating guidance to better test and certify thermal packaging. As the author’s of the industry standard, ISTA temperature profiles we understand the critical role temperature profiles play in the accuracy of a pack-out design. ISTA provides testing and certification for transport packaging to ensure it can withstand the physical challenges of the distribution environment, which is crucial for temperature-controlled shipping.
Parenteral Drug Association (PDA)
The PDA offers resources and training on the best practices for the distribution and shipping of pharmaceuticals, including cold chain management. They provide guidelines and standards for companies involved in the pharmaceutical supply chain. The PDA interest group Pharmaceutical Cold Chain Interest Group (PCCIG) provides scientific, technical and regulatory information on pharmaceutical and biopharmaceutical manufacturing and quality worldwide.
Cool Chain Association (CCA)
As former scientific advisors for Cool Chain Association (CCA), our team contributed to multiple advisory teams, presentations and publications. CCA is a non-profit organization bringing together all parts of the temperature-sensitive supply chain to create an impact with visible and measurable results both for companies and for society. CCA aims to reduce wastage and improve the quality, efficiency, and value of the temperature-sensitive supply chain by facilitating and enabling vertical and horizontal collaboration, education, and innovation amongst members and stakeholders.
ISPE (The International Society for Pharmaceutical Engineering)
As a former contributor to the ISPE (The International Society for Pharmaceutical Engineering) Good Practice Guide: Cold Chain Management, our team helped ISPE to provide essential information to all scientific and technical areas of the pharmaceutical manufacturing industry that are represented among the ISPE Membership. Engineers, microbiologists, chemists, QA/QC, production, process development, pharmacists, regulatory and training personnel, academia, suppliers, and other professionals contribute their expertise to the industry through their participation in ISPE activities. The International Society for Pharmaceutical Engineering is a nonprofit association serving its Members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle.
International Air Transport Association (IATA)
As the scientific advisor for eight years on perishable and pharmaceutical products our experts thoroughly understand the challenges and solutions around air transportation. IATA provides guidelines and certifications for the air transport of pharmaceuticals, including cold chain products. The IATA’s Center of Excellence for Independent Validators (CEIV) in Pharmaceutical Logistics is a globally recognized certification that ensures companies comply with all applicable standards, regulations, and best practices for the transport of pharmaceuticals.
United States Pharmacopeia (USP)
USP offers standards and guidelines (like USP <1079> Good Storage and Shipping Practices) that cover aspects of the proper storage and transportation of pharmaceuticals, including those requiring cold chain management.
Dr. Jeff Mesaros
Contact our team of experts today for any of your cold chain accreditation and regulatory consulting needs.
Dr. Mesaros, an experienced pharmacist attorney, consults on a wide array of business and healthcare matters. Jeff specializes in pharmacy law, practice, and operations, including healthcare technology, delivery models and supply chain solutions. Dr. Mesaros is a Florida Board of Pharmacy Member and serves as President-Elect of the National Association of Boards of Pharmacy Executive Committee.