Regulatory Audits and Compliance Gap Analyses are essential in identifying compliance deficiencies and assessing regulatory risk. Regulatory Compliance Associates Inc. will help to identify deficiencies, provide options to correct each deficiency, and will help you choose the best solution for your company.
We will help you with the following:
- Perform cGMP compliance audits for manufacturing, pilot plant, and laboratory facilities
- Perform Regulatory Gap Analyses, which compare approved submission commitments to actual conditions and practices in manufacturing operations
- Prepare Risk Assessments, which identify a recognizable methodology for decision making
- Perform Pre-Approval trial audits in preparation for an FDA inspection
- Perform Part 11 Gap Analysis for computer and automated systems