CORE SERVICES
Sanitary Surveillance
Sanitary Surveillance
Sanitary surveillance is essential for ensuring the safety and effectiveness of pharmaceutical products. Our services focus on monitoring, detecting, and assessing adverse effects, maintaining rigorous safety standards throughout a product’s lifecycle. We use real world data to provide comprehensive support, including data collection, analysis, and regulatory reporting, to help companies meet requirements and protect patient health.
Regulatory Reporting:
It is important to ensure that all documentation produced is accurate and complies with the relevant regulations. Our team of experts ensures that all documents are up to date, that all regulations are respected and that there are no issues with documentation.
Risk identification:
Gathering reports on adverse events (AEs) from healthcare professionals, patients, and manufacturers, our team then documents and communicates these events to the relevant regulatory authorities.
Risk Assessment:
Once risk has been identified it is important to assess their severity and their links to affected products. At LAMA we act as liaison between manufacturer, MoH and those who identified the risk in order to complete this assessment process.
Risk Management:
Once risk has been assessed we must build a strategy to manage this, with the end goal of minimizing risks. This process is treated on a case-by-case basis and could consist of adjusting labelling, altering dosage recommendations or, in extreme cases, removing products from the market.
Audit planning and training:
At LAMA we provide tailored audit strategies to identify compliance gaps and areas for improvement, while our training programs equip your team with the skills needed to maintain high standards of quality and regulatory adherence.
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