Expertise From Experience

Three Decades Of International Results

Expertise From Experience

Three Decades Of International Results

CGMP and Regulatory Guidance From the Front Lines

What better way to steer clear of compliance and regulatory problems than to work with former FDA Investigators, those who trained them, and those who helped launched inspection programs?

Who better to help you correct problems than those who managed the inspections, participated in FDA compliance actions and managed their follow-ups?

Insight from both sides of inspections

InterProQRA personnel combine decades of frontline FDA compliance leadership and extensive pharma experience to deliver true insight—wisdom gained from working on the government and industry sides of the regulatory table.

Domestic or International

Location is inconsequential. InterProQRA consultants have led inspections and regulatory activities throughout the United States and around the world, with international experience that includes building expertise and developing training programs for manufacturers of pharmaceutical dosage forms and APIs for distribution in the US.

Around the corner or around the world, we know what’s critical for your regulatory success.

Solutions From FDA-Trained Investigators

Implement corrective actions and remediation

  • Prepare responses to FDA Form 483 Observations
  • Prepare remediation and subsequent responses to Warning Letter Charges, including reinspection assessment and correspondence with FDA

Maintain cGMP compliance

  • Pre-inspection preparation audits
  • Review Quality Systems for compliance
  • Provide onsite, real-time support during FDA inspections

Bring facilities into compliance

  • Support the approval process of NDAs and ANDAs

Prepare for facility inspection

  • Initial or subsequent FDA inspections (active pharmaceutical ingredients and finished dose)

Qualify suppliers and contract manufacturing services

  • Including laboratories, CMOs, and 3PLs