In today’s regulated markets, pharmacovigilance plays a crucial role in ensuring the safety and well-being of patients. It involves the collection, assessment, monitoring, and prevention of adverse effects or any other drug-related problems. At Saba Regulatory, we understand the significance of pharmacovigilance and its impact on public health.
Our dedicated team of experts specializes in providing comprehensive pharmacovigilance services tailored to meet your specific needs. We work closely with pharmaceutical companies, biotechnology firms, and medical device manufacturers to establish robust pharmacovigilance systems and ensure compliance with local and international regulations.
By partnering with Saba Regulatory for your pharmacovigilance needs, you can trust that your safety reporting and monitoring processes are in capable hands. We are committed to ensuring patient safety, regulatory compliance, and the overall success of your pharmacovigilance activities.
We assist in setting up a robust pharmacovigilance system in line with local regulations.
Our team helps establish standard operating procedures (SOPs) for effective adverse event reporting and management.
We ensure proper handling and reporting of safety data between the Marketing Authorization Holder (MAH) and regulatory authorities.
Our experts facilitate the timely submission of required pharmacovigilance reports, such as Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs).
We provide support in developing and maintaining the Pharmacovigilance System Master File, which outlines the pharmacovigilance system and processes implemented by the company.
Our team conducts training sessions for healthcare professionals and staff involved in pharmacovigilance activities.
We ensure that responsible personnel are well-equipped with the knowledge and skills required for accurate adverse event reporting and compliance with pharmacovigilance regulations.
We assist in preparing for regulatory audits and inspections by providing guidance and support.
Our team helps address any identified gaps or issues to ensure compliance with pharmacovigilance requirements.
Saba Group: Empowering Regulatory Success in Iraq Since 2008. With a proven track record, we have successfully registered over 250 production sites and more than 1000 products.
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Bataween Dist. 101 Block 77, House No:59, Baghdad, Iraq
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