Remediation and Response Services 

Regulatory Agency Response Services

ProPharma's expert team collaborates closely with your organization to drive effective remediation and regulatory response strategies.

Assemble an Action Team:
We assemble an action team of internal and external experts, led by ProPharma's seasoned professionals, to ensure a compliant remediation process. We recommend that you involve key personnel from Management, Quality Assurance, Operations, Compliance, and Regulatory Affairs. 

Draft the Response:
ProPharma's experts draft a clear and comprehensive response to regulatory agencies by:

• Addressing Each Observation: Explaining corrective actions with specific timelines.
• Root Cause Analysis: Summarizing investigations into the root causes.
• Corrective and Preventive Actions (CAPA): Outlining a plan to correct current issues and prevent recurrence.

Monitor and Follow-Up:
After submitting your response, it’s important to monitor the implementation of corrective actions and ensure their effectiveness. ProPharma assists in: 

• Tracking Progress: Regularly reviewing remediation efforts to ensure timely completion.
• Evaluating Effectiveness Checks: Verifying executed actions were successful to prevent recurrence.
• Continuous Improvement: Identifying opportunities to enhance compliance and operational excellence.
• Verifying Supporting Documentation: Evaluating documentation to ensure evidence is sufficient to support your response. 

Comprehensive Compliance Assessments

We start with a detailed assessment of your facility, processes, and documentation to confirm agency findings and identify additional non-compliance areas. Our experts review your quality management systems, manufacturing practices, and operational procedures, identifying gaps against regulatory requirements and industry best practices.

Beyond addressing cited issues, we proactively identify related problems across systems, facilities, or production lines to prevent recurrence and demonstrate systemic resolution.

Understanding the root causes of deficiencies is crucial. We conduct in-depth investigations using root cause analysis techniques to address system weaknesses, procedural lapses, or human errors, ensuring long-term compliance.

We prioritize findings based on their severity, impact on product quality, and regulatory implications, providing clear recommendations for a structured and efficient remediation process.

A comprehensive report, including findings, root cause analysis, and a prioritized action plan, is provided as a roadmap for your remediation efforts, ensuring clear and actionable steps toward regulatory compliance.

Strategic Remediation Planning

We partner with your team to develop a comprehensive plan to address your remediation activities:

• Understanding Regulatory Observations: Thoroughly reviewing each observation and inspection report, and engaging with your stakeholders to ensure accurate interpretation.
• Prioritizing Issues: Helping prioritize compliance gaps based on their severity, impact on product quality, and regulatory implications, ensuring critical concerns are addressed first.
• Outlining CAPA: Developing a detailed Corrective and Preventive Actions (CAPA) plan for each issue, specifying actions, responsible personnel, and timelines for implementation.
• Proposed Timelines: Providing realistic timelines for each corrective action, ensuring a structured and time-bound remediation process.
• Integrating Continuous Improvement: Incorporating continuous improvement practices into your quality management systems for proactive compliance and operational excellence.

Expert Project Management

ProPharma’s project managers oversee the remediation process, coordinating activities, meeting timelines, and optimizing resources. We provide ongoing support and regular progress updates, addressing potential delays and proposing solutions to keep the project on track.