Pharmaceutical Manufacturers

Consulting for Pharmaceutical Manufacturers who Distribute

In today’s ever-evolving regulatory landscape, pharmaceutical manufacturers face mounting pressures to maintain compliance across every stage of sales and distribution. Our regulatory consulting services are tailored to protect your business and accelerate growth—whether you are launching new products, expanding your distribution footprint, or navigating complex state and federal requirements.

With over 30 years of direct industry experience and a deep understanding of FDA, DEA, and state regulations, we provide manufacturers with expert guidance.

Who We Serve

  • Traditional Manufacturers

  • Virtual Manufacturers

  • Specialty Manufacturers

  • Repackaging Operations

  • Contract Manufacturers


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Licensing & Accreditation

Streamline your licensure across all 50 states and secure NABP Drug Distributor Accreditation (formerly VAWD) with confidence.

Compliance Programs

Develop and implement robust policies and SOPs to address DSCSA requirements, suspicious order monitoring, diversion prevention, and recordkeeping.

Audit Readiness

Prepare for FDA, state, or third-party inspections with gap assessments, mock audits, and corrective action plans.

Regulatory Defense

Rapid response to warning letters, Form 483s, or enforcement actions, including remediation strategies and direct liaison with regulators.

Supply Chain Risk Management

Identify vulnerabilities in your distribution channels, conduct due diligence on trading partners, and implement controls to prevent counterfeit or diverted product entry.

Training & Education

Equip your team with the latest regulatory knowledge, including DSCSA updates, traceability requirements, and best practices for compliant distribution.