Remediation Consulting Services

Regulatory Compliance Associates has significant quality and regulatory compliance consulting experience and a proven regulatory framework for managing FDA  483’s, Warning Letters, and Consent Decrees. Our pharmaceutical consultants know how to partner with executive, legal, and communication teams at all levels of a life science company. RCA’s remediation consulting experts can assist your management with a remediation strategy that is accepted by the regulatory agency and realistic to execute internally.  Finally, RCA can partner with your leadership team to develop a long-term risk management plan to help your team stay in compliance going forward.

Regulatory Compliance Associates can assist with answering FDA 483 observations, FDA Warning Letters and developing strategies to help your organization maintain regulatory compliance through continuous improvement.

RCA can help with remediation activities in both manufacturing operations & quality management systems.  RCA’s regulatory consultants have completed many projects assisting our clients to evaluate what is needed, collaboratively determine action plans & help execute.  We have also performed post-implementation audits to ensure regulatory compliance.

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Examples of RCA’s remediation services include:

• Assistance with responding to FDA 483 Observations and Warning Letters
• Develop strategies and define tactical actions to regain compliance with US FDA and other regulatory bodies
• Responding and acting upon Complete Response Letters (CRL)
• Perform oversight activities for manufacturing, production & QC testing including:
  • Interim Controls and other third party oversight services
  • Communications with the FDA
    • Assistance with preparing for FDA meetings
    • Responding to FDA communications and other compliance and enforcement related activities

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].