Consulting Services for Controlled Substances & Listed Chemicals Regulated by the Drug Enforcement Administration (DEA)
Our Consulting Services
Providing comprehensive services for all levels of domestic and international pharmaceutical and chemical firms, governments, associations, and companies entering the controlled substance or listed chemical business.
Controlled substance and listed chemical regulatory guidance and associated services.
Assistance with controlled substance scheduling, abuse liability assessment, registration, manufacturing processes, import/export applications, DEA record-keeping and reporting, including ARCOS, submitting applications for quotas, and security systems.
Specialized evaluation, design, and implementation of long-term controlled substance and listed chemical business strategies.
Identification and resolution of regulatory challenges.
Evaluation and design of required record-keeping and security systems, procedures, and policies to meet and exceed compliance with federal and state requirements.
Conduct on-site "mock DEA inspections" to determine the level of compliance with DEA requirements.
Assistance with Suspicious Order Monitoring (SOM) programs.
Assistance with controlled substance clinical trial design, site start-up, and monitoring.
Assistance with Risk Evaluation and Mitigation Strategies (REMS).
Guidance on the acquisition of firms with existing DEA registrations.
Training on controlled substance and listed chemical issues, DEA policies and procedures, and specialized matters designed to meet your needs.