Quality Management
We provide a comprehensive range of quality management services designed to help companies implement and maintain robust quality systems. Our services focus on ensuring compliance with Good Manufacturing Practices (GMP), preparing for regulatory inspections, and developing risk management frameworks that mitigate quality-related issues.
HOW WE CAN HELP
We’ll ensure that you focus on the opportunities
End-to-end programs.
At PharmAdvis Solutions LLP, we help you streamline and enhance your quality management processes by offering end-to-end programs that cover every aspect of compliance and quality assurance. We’ll ensure that you focus on the opportunities for continuous improvement while we address the complexities of regulatory compliance, risk management, and inspection readiness. From initial assessments to post-audit support, we provide comprehensive solutions to help you maintain high-quality standards and meet global regulatory requirements.
We’ll ensure that you focus on the opportunities
End-to-end programs.
GMP Remediation
We perform in-depth assessments and create tailored remediation plans to address compliance gaps, ensuring your manufacturing and testing facilities achieve and maintain full GMP compliance.
Validation Services
We offer comprehensive validation support for your manufacturing processes, equipment, cleaning procedures, and computerized systems, adhering to global regulatory standards like GMP, FDA, and EU requirements.
Inspection Readiness
Our team prepares your organization for regulatory inspections by conducting thorough mock audits, identifying gaps, and implementing Corrective and Preventive Actions (CAPA) to minimize the risk of findings during actual inspections.
Quality Auditing
Our experts conduct thorough internal and external audits, including detailed vendor and Contract Manufacturing Organization (CMO) assessments, to ensure compliance with industry standards and regulations across your supply chain.
Risk Assessment & Management
We help you establish risk-based quality management systems by conducting root cause analysis and developing proactive mitigation strategies that enhance product safety and ensure regulatory compliance.
Continuous Improvement
We focus on building systems for continuous quality improvement, incorporating metrics for ongoing monitoring and updates to ensure your operations meet evolving regulatory expectations and business goals.
Numbers
Client results
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Frequently Asked Questions
GMP remediation is the process of addressing compliance gaps in Good Manufacturing Practices to ensure that facilities and processes meet regulatory standards. It’s essential to avoid costly regulatory findings and to ensure product safety and quality.
We conduct mock audits, gap assessments, and provide Corrective and Preventive Action (CAPA) implementation. Our team prepares your organization for inspections by identifying potential deficiencies and creating action plans to mitigate risks.
We offer validation services for manufacturing processes, equipment, cleaning procedures, and computerized systems to ensure they meet regulatory standards such as FDA, GMP, and EU requirements.
We develop risk-based quality management systems by performing root cause analyses and implementing strategies to mitigate risks. This ensures product safety and regulatory compliance.
Our quality auditing services include internal and external audits, vendor audits, and Contract Manufacturing Organization (CMO) assessments to ensure that your operations and partners meet regulatory and quality standards.
We provide continuous monitoring and improvement programs to help companies stay compliant with evolving regulations and maintain robust quality systems.
We primarily serve the pharmaceutical and biopharmaceutical industries, but our quality management services can be tailored to any regulated industry requiring compliance with GMP standards.
Internal audits should be conducted regularly, typically at least once a year, or more frequently depending on the complexity of operations and regulatory requirements.
A risk-based approach focuses on identifying and managing risks that could impact product quality or safety. It helps prioritize resources to mitigate the most significant risks first, ensuring regulatory compliance and operational efficiency.
Yes, we offer customized training programs tailored to your team’s needs, covering topics like GMP compliance, risk management, CAPA implementation, and audit preparedness.
“Working with PharmAdvis Solutions LLP has been a transformative experience for our company’s quality management processes. Their expertise in GMP remediation and inspection readiness has been invaluable. From the very beginning, the PharmAdvis team conducted thorough assessments and provided us with actionable insights that helped us address compliance gaps effectively.
Their mock audits and gap assessments prepared us exceptionally well for our regulatory inspections, leading to successful outcomes without any findings. The tailored training programs on risk management and quality systems have empowered our staff, ensuring we maintain high standards and compliance at all levels.
PharmAdvis didn’t just help us meet regulatory requirements; they fostered a culture of continuous improvement within our organization. Their commitment to quality and professionalism truly sets them apart. I highly recommend PharmAdvis Solutions LLP to any company looking to enhance their quality management practices!”
arol Aviana,
Head,Quality Control
Bayer Pharmaceutical Ltd