Explore Our Expert DEA Compliance and Supply Chain Security Services

At GTC Consulting, we are dedicated to providing comprehensive services that ensure both regulatory compliance and the protection of high-value drug products throughout the supply chain. Our team of experts offers tailored solutions to meet the specific needs of your organization.

Regulatory Affairs

• DEA Registration & Compliance Management Support with new and renewal registrations, modifications, recordkeeping, reporting, and quota/import-export compliance.
• Audit Readiness & Enforcement Support Mock inspections, internal audits, SOP development, and assistance during DEA inspections or enforcement actions.
• Security, Monitoring & Training Programs Controlled substance security planning, suspicious order monitoring (SOM) system design, and staff training on DEA compliance and diversion prevention.
• Suspicious Order Monitoring (SOM) Program design, implementation, enhancement, system validation, and performance evaluation.
• Know Your Customer (KYC) Inspections Professional due diligence evaluations/audits on supply chain trading partners.

Accreditation

• NABP Drug Distributor Accreditation (DDA)

Litigation Support

• Expert Witness (Controlled Substances)
• Government DEA/DOJ

Pharmaceutical Licensing

• Professional Licensing Researchers, pharmacists, and prescribers.
• Business Licensing Manufacturers, Repackagers, 3PLs, Distributors, Hospitals, Pharmacies, Treatment Facilities, Analytical Laboratories, and Import/Export Businesses.

Advisory

• Security Strategy & Implementation Controlled substances and high value drug products (e.g. GLP-1 – Wagovy, Ozempic etc.)
• Mergers & Acquisition Support Expert liability evaluation and risk mitigation strategy development.
• Investor & Stakeholder Provides strategic advice to investors and stakeholders to effectively mitigate non-compliance liabilities and protect the legitimate interests of the company, healthcare, and the public.