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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.
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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