Whether you are in the early stages of managing responses to FDA 483 observations, delivering on commitments to FDA as part of a Warning Letter or Consent Decree or, you have successfully satisfied FDA and you are in the end stages of returning to a new state of normal operations, you can never go back. You must maintain your laboratory operations in a state of current good manufacturing practice (cGMP) compliance at all times.

Examples of areas in which Regulatory Compliance Associates^® Inc. can provide laboratory compliance support include:

• On-site inspections, i.e., Gap Assessment, General GMP, FDA Readiness, etc.
• Data Integrity Verification, i.e., OOS, OOT, Notebook Audit, Forensic Evaluation, etc.
• Calibration / Metrology Program Assessment
• Method Development and Validation Assessment
• Stability Study Program Assessment
• WFI Process Verification
• Risk Assessment for Modifications to Existing Labs or Build Out of New Labs