Gap Analysis and Assessment:
We begin by conducting a thorough evaluation of your current quality systems to identify areas of non-compliance, inefficiencies, and opportunities for improvement. This includes reviewing documentation, processes, and practices in accordance with regulatory standards such as GMP, FDA, EMA, and ICH.
Regulatory Compliance Strategy:
Curedose Pharma helps create a customized remediation plan tailored to your organization’s needs, aligning it with global regulatory requirements. Our team ensures that all quality systems are compliant with the latest guidelines, mitigating risks and ensuring uninterrupted business operations.
Corrective and Preventive Action (CAPA):
We support the development and implementation of effective CAPA plans to address identified issues and prevent future occurrences. This includes corrective actions, process optimization, and training initiatives for staff.
Document Control and Review:
We assist in revising and updating essential documentation such as Standard Operating Procedures (SOPs), batch records, and compliance reports, ensuring that they meet regulatory standards and facilitate accurate, streamlined audits.
Process Optimization and Validation:
Our experts optimize quality control processes, ensuring that the systems in place are efficient, reliable, and capable of producing high-quality pharmaceutical products. This includes process validation, equipment qualification, and analytical method validation.
Training and Knowledge Transfer:
A critical part of remediation is ensuring that your team is trained in best practices, regulatory requirements, and the proper execution of quality systems. Curedose Pharma offers training programs to ensure the longevity and sustainability of remediation efforts.
Ongoing Monitoring and Support:
After implementation, we provide continuous support and monitoring to ensure that your quality systems remain compliant and are continuously improved. We offer periodic reviews and audits to maintain the highest level of operational efficiency and regulatory compliance.
