Remediation and Response Services 

ProPharma combines deep industry knowledge with a personalized approach to ensure your compliance efforts are effective, timely, and aligned with regulatory expectations.

Ensure Regulatory Compliance with ProPharma's Remediation and Response Services

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Regulatory Agency Response Services

Regulatory Agency Response Services

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Comprehensive Compliance Assessments

Comprehensive Compliance Assessments

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Strategic Remediation Planning

Strategic Remediation Planning

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Remediation Implementation Support

Remediation Implementation Support

When your company receives observations, a Form 483, or a Warning Letter from the FDA or another regulatory agency, a timely and thorough response is crucial. ProPharma's Regulatory Agency Response Services are designed to help you navigate this complex process with confidence and precision.

Before drafting your response, it’s essential to step back and form a comprehensive plan of action. Our experts assist you in developing a structured and strategic plan to address the regulatory findings effectively. This involves understanding the regulatory observations in detail, prioritizing the issues based on their severity and potential impact, and outlining the steps needed to address each one.

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When the FDA or other regulatory agency identifies observations and areas for improvement, it is important for the company to conduct a thorough assessment of all GxP systemsTo ensure objectivity and accuracy, we recommend seeking the help of third-party experts to conduct independent assessments. At ProPharma, we will validate the observations noted by the regulatory agency, ensuring a complete understanding of the issues and their root causes. We proactively identify other potential compliance risks across your systems, facilities, and processes. This comprehensive approach helps prevent future regulatory issues and promotes overall operational excellence. 

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ProPharma's strategic remediation planning services provide a comprehensive roadmap to address regulatory findings and ensure long-term compliance. Effective remediation requires more than just addressing immediate concerns; it involves developing a strategic plan that ensures sustainable compliance and continuous improvement. Our strategic remediation planning services help you navigate this complex process with precision and foresight. 

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The transition from planning to implementation is critical to the success of any remediation effort. ProPharma’s Remediation Implementation Support services are designed to guide you through this process, ensuring that corrective and preventive actions are executed effectively and efficiently. ProPharma's Remediation Implementation Support services ensure the successful execution of your strategic remediation plan, driving compliance and operational excellence across your organization.

Our team of quality and compliance experts provides hands on support and comprehensive guidance on navigating the complexities of GxP compliance. Whether you need support with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), or other GxP standards, ProPharma can provide you with industry experts equipped to address your specific needs. With extensive experience across almost every facet of healthcare, our team has completed thousands of projects, delivering compliant and effective solutions tailored to your unique challenges.

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Expert Guidance for Your Compliance Needs

Ensure your organization meets regulatory standards with a comprehensive, expert-led approach to remediation. Connect with our specialists today to develop a tailored plan that addresses your compliance challenges effectively and efficiently.

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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. 
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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.
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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.

Regulatory Action Types

European Medicines Agency (EMA)

Warning Types:
  • Non-Conformance Report (NCR)
  • Inspection Report
  • Statement of Non-Compliance
  • Suspension/Withdrawal of Marketing Authorization 
  • CAPA Request (Corrective...
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European Medicines Agency (EMA)

Warning Types:
  • Non-Conformance Report (NCR)
  • Inspection Report
  • Statement of Non-Compliance
  • Suspension/Withdrawal of Marketing Authorization 
  • CAPA Request (Corrective and Preventive Actions)
Read Less

Medicines and Healthcare products Regulatory Agency (MHRA)

Warning Types:

  • Inspection Action Group (IAG) Meeting
  • Compliance Notice
  • Improvement Notice or Regulatory Action
  • Non-Compliance Report

Medicines and Healthcare products Regulatory Agency (MHRA)

Warning Types:

  • Inspection Action Group (IAG) Meeting
  • Compliance Notice
  • Improvement Notice or Regulatory Action
  • Non-Compliance Report
Read Less
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