Built to Protect. Powered by Compliance.

Your First Line of Defense in Pharmaceutical Distribution Compliance

When regulations threaten your pharmacy, manufacturing, or distribution business, RegShield Rx delivers rapid response, expert problem-solving, and long-term compliance confidence. Our expertise guides you through license gaps, audits, FDA/DEA reviews, and DSCSA requirements—so your operation thrives, not just survives.

Regulatory Enforcement Trends Last Ten Years (2014-2024)

OVER 1,000 - FDA WARNING LETTERS

$13 BILLION - FINES AND PENALTIES

90 - CRIMINAL CONVICTIONS

OVER 220 YEARS - PRISON SENTENCING

OVER 1,000 - FDA WARNING LETTERS $13 BILLION - FINES AND PENALTIES 90 - CRIMINAL CONVICTIONS OVER 220 YEARS - PRISON SENTENCING

Our Services

  • FDA Warning Letter Defense and Prevention

    Prevention and Cure

    Whether you’re preparing for an FDA Compliance Audit or Reviewing a recent FDA Notification. RegShield Rx can help expand and protect your BRAND no matter what the circumstance!

  • Accreditation Navigation

     No Waiting

    Strategic Planning, Navigation and Expert Communication is crucial to the overall success of any accreditation process. RegShield Rx provides timetables and deliverables that are prioritized for efficiency, lower cost and ease of fulfillment.

  • Audit Armor

    Inspection Readiness or Remediation

    Put on your inspector boots and walk around your facility with RegShield Rx for all the latest in compliance protection.  Checkboxes are not a problem with our pre audit inspections or due-diligence review of facilities and/or customers. Protection delivered to your doorstep!!

  • StateLine Rx Compliance

    From Application to Renewals and Everything in Between

    State by State for Manufacturers, Distributors or 3PL’s, RegShield Rx keeps products moving without unnecessary delays. Scalable Protection for a specific product launch or for all U.S. States and Territories.

  • SOP Force

    Wash, Rinse, Repeat

    Meaningful Standard Operating Procedures that are drafted to meet Compliance Guidelines and Best Business Practices can strengthen your position in the marketplace and provide invaluable compliance protection. At RegShield Rx, we use human eyes to create or review SOPs unique to each facility’s operations.

  • Acquisitions & Mergers

    Horizontal, Vertical or Upside Down

    Don’t sign that final transaction document just yet! Let RegShield Rx do a deep dive into the licensing, violations and geographical scope of the target company. Then, if cleared, we can assist with change of ownership documentation and new licensing, if required, for all regulatory authorities.

Appointments