Compliance Remediation

Permanent Injunction, Consent Decree, Warning Letter, FDA 483 Remediation and 3rd Party Verification Audits

JYA consultants understand the urgency our consultants will work with your team to develop an audit program that supplements or serves in place of your internal capabilities. We have expertise in designing audit programs for early stage clinical trials through post-commercialization. Our programs are designed to address the following areas:

GMP Remediation
Engaging a regulatory consultant to help with

  • FDA 483 and Warning Letter responses
  • Failure investigations
  • Consent Decree remediation
  • Project management for all remediation programs
  • Failed PAI Inspections
  • Coordinating recall efforts
  • Import detention resolution

Strategic Regulatory Consulting

  • Computer Systems Validation (CSV) audits
  • 21 CFR part 11 compliance review
  • Database audits
  • Trial Master File audits