Achieving Compliance at Your Compounding Pharmacy
Compounding pharmacies is a growing segment of the industry with continuing emerging regulations. The ever-evolving landscape of industry regulations requires strict monitoring of quality standards. Regulatory Compliance Associates® is a leader in both aseptic drug manufacturing and the compounding pharmacy industries. Our regulatory experts can guide these entities to ensure they demonstrate compliance with new federal compounding industry regulations and meet the most Current Good Manufacturing Practices (cGMP) guidance requirements.
Regulatory Compliance Associates® can also prepare and train personnel in the management of FDA follow-up inspections. Regulatory Compliance Associates® can help your company strategically address quality compliance issues and help you establish a robust quality system designed to meet current FDA expectations for 503b compounding pharmacies. We do this through:
- Comprehensive Baseline Reviews
- Development and Documentation of Processes and Procedures
- Review and Guidance with Product Labeling Requirements
- Preparation, Management, and Response to an FDA Inspection
- Remediation
- Shop Floor Quality
- Batch Record Review and Release
- Investigations
- Third Party Oversight
- Re-engineering of a Facility (if needed)
RCA has the experience and insights to guide Compounding Pharmacies down the complicated path of compliance. We help companies navigate complex regulations for Combination Products to increase their successful launch and steer biologics manufacturers through their entire lifecycle.