Audit and Compliance
We excel in providing comprehensive audit and compliance services in pharmacovigilance, ensuring adherence to stringent regulatory requirements such as ICH guidelines and GVP modules. Our expertise includes conducting thorough audits, gap assessments, and mock inspections to prepare organizations for regulatory scrutiny in addition to providing specialized training to enhance staff awareness and maintain compliance with pharmacovigilance standards
DISCOVER MOREPharmacovigilance Audits and Inspection
Regulations are stringent to guarantee maximum patient safety during every phase of drug development. As pharmaceutical products evolve from research to post-marketing activities, they must comply with laws, procedures, and guidelines established by regulatory authorities. Routine reviews of pharmacovigilance and quality systems are essential to verify that they remain effective.
DDReg’s audit personnel meticulously assess pharmacovigilance systems, ensuring adherence to regulatory standards such as ICH guidelines, E2B(R3), E2C(R2), and various GVP modules. Our experts also provide targeted training in PV audit practices, ensuring that staff understand and implement the necessary procedures to maintain compliance.
Ensuring Regulatory Compliance in Pharmacovigilance
Pharmacovigilance activities are pivotal in safeguarding public health. As the pharmaceutical industry evolves, robust compliance measures become even more critical. The Safety Data Exchange Agreement (SDEA) serves as a framework for sharing safety information among stakeholders, fostering transparency and collaborative drug safety surveillance. Regular audits verify that these agreements are maintained and that all systems are operating in line with regulatory mandates.
Audits are integral to evaluate the effectiveness of pharmacovigilance systems. By conducting detailed reviews, our team helps ensure that adverse events are reported promptly and that risk management strategies are both effective and proactive. This process—often referred to as a PV audit—is a cornerstone in reducing the risk of non-compliance and improving overall drug safety.
Our Audits & Compliance Expertise
- Highly experienced and trained professionals in pharmacovigilance audits
- Review of compliance against applicable PV guidelines, Safety Data Exchange Agreements (SDEAs), SOPs, and work instructions
- Optimized audit plans and mock audits to prepare organizations for regulatory inspections
- Regular gap assessments of PV staff at various site locations
- Organizational training on safety audits and inspections
Ready to enhance your drug safety audit processes and ensure full regulatory compliance?