InterPro QRA

Services

Expert guidance through today’s regulatory landscape

InterProQRA is a dynamic, global consulting practice specializing in CGMP compliance and FDA regulatory adherence. We deliver comprehensive solutions to pharmaceutical/biologic companies of every size.

Our team is uniquely qualified to help you manage compliance and regulatory challenges and to efficiently address those that may arise. Combining decades of boots-on-the-ground FDA evaluation and enforcement experience with extensive consulting work for pharmaceutical clients, our team applies the insight and foresight that only comes from working both sides of the Quality table.

Comprehensive services

CGMP Compliance Solutions

  • Regulatory preparedness/gap analysis
  • Auditing; qualification, pre-inspection and due-diligence

Enforcement Guidance

  • 483 Response
  • Warning Letter
  • Consent Decree

Training

  • Annual CGMP
  • Aseptic processing
  • How to interact with the FDA

Construction Projects

  • Design guidance
  • Audits during construction through validation

Need Regulatory Guidance?

Get Help From The Source

Click below to download our brochure and learn more about how you can anticipate and resolve violations before they happen.

View The Brochure