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Pharmaceutical
Knowledgeable Experts
In the highly regulated pharmaceutical industry, our company offers a range of expert solutions designed to address critical needs and mitigate potential risks. Our robust drug diversion program and policy development expertise ensures strict compliance with the Controlled Substances Act (CSA) and Code of Federal Regulations (CFR), safeguarding your operations against legal and reputational challenges that can arise from enforcement actions. With a proven track record in the field, we understand the intricacies of regulatory compliance and provide tailored solutions to protect your pharmaceutical enterprise.
“Tenet Healthcare identified a need for our security personnel and other team members to receive training on Fentanyl and the safe handling of illicit drugs. We hired Guidepost Solutions based on their extensive DEA field experience as well as their certification as DEA instructors. Susannah Herkert delivered an impactful, sensical, and detailed training on fentanyl and safe handling practices for illicit drugs. We are grateful for the training and the safe environment it promoted for our team members.”
Sonia Johnson, Corporate Security Zone Leader (Regional Manager) over all Tenet Healthcare Special Investigations
Comprehensive Approach for Well Rounded Solutions
Our DEA Regulatory Compliance practice is made up of nationally respected, multi-disciplinary experts in the Controlled Substances Act (CSA) and the Code of Federal Regulations (CFR). The team includes former DEA attorneys and compliance experts, Diversion Investigators, and Special Agents. Our experts can outline the appropriate steps to ensure fulfillment of the regulatory requirements of a DEA registration and help avoid the financial and reputational risk that can result from noncompliance, including potential enforcement actions.
Additionally, our comprehensive approach extends to both physical and cyber security assessments and designs. We evaluate your existing security measures and fortify them against evolving threats, providing a secure environment for sensitive pharmaceutical operations. In the era of heightened global scrutiny, our expertise in Committee on Foreign Investment in the United States (CFIUS) compliance ensures that your international clinical trials remain in line with national security requirements. We also offer risk assessment services, helping you proactively identify and mitigate potential vulnerabilities.
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