Our solutions support sponsors and investigators in maintaining continuous oversight of the benefit-risk balance of investigational medicinal products. We achieve this through a straightforward approach that aligns with the sponsor’s goals, evaluates the product’s safety profile, and applies robust regulatory intelligence to navigate guidelines and compliance requirements efficiently.intelligence to navigate guidelines and compliance requirements efficiently.
The appointment of a QPPV is a mandatory requirement in regions such as the European Union (EU) and is increasingly being adopted across Africa. The QPPV is responsible for establishing and maintaining pharmacovigilance system that ensures the safety of medicinal products and compliance with regulatory standards. Similarly, LPPVs address country-specific pharmacovigilance requirements, ensuring local compliance and effective communication with national health authorities.
Our Post-marketing Pharmacovigilance services involve the continuous collection, assessment, and analysis of adverse events data from various sources, including healthcare professionals, patients and literature. We ensure compliance with global regulatory requirements while safeguarding public health by identifying, assessing, and mitigating potential safety risks associated with the product.
Individual Case Safety Report (ICSR) case collection and processing is at the heart of pharmacovigilance, either clinical or post-marketing. Our solutions ensure effective and efficient case management by collecting detailed data, assessing the severity and causality of each case, and ensuring proper follow-up actions. Case processing and quality review are closely interconnected, so we prioritize adherence to timelines, industry standards, and submission requirements set by regulatory authorities.
We offer tailored case processing services designed to align with the specific needs of each client and their pharmacovigilance system.
Our Signal Management services combine advanced technology with expert analysis to detect and assess emerging safety concerns throughout the clinical development and post-marketing phases of a product's lifecycle. By utilizing automated data processing, real-world evidence, and comprehensive safety databases, we systematically analyze diverse sources, including adverse event reports and scientific literature. This approach enables us to identify potential risks early, prioritize critical signals, and conduct thorough evaluations to determine their clinical and regulatory impact.
We prepare and submit comprehensive safety reports, including Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Evaluation Reports (PBRERs) to regulatory authorities. These reports consolidate safety data over a defined period, providing a thorough analysis of a product’s benefit-risk profile. Our expert team ensures compliance with international standards, supporting clients in maintaining product safety and regulatory transparency throughout the product lifecycle.
THESYL offers comprehensive Risk Management Plan (RMP) services to ensure the safe use of pharmaceutical products. The services includes the development, implementation, and continuous evaluation of RMPs, tailored to align with each product's unique safety profile. By working collaboratively with our clients, we identify potential risks, propose effective Risk Evaluation and Minimization Strategies (REMS), and monitor the ongoing effectiveness of these measures.
Our RMPs are designed to comply with regulatory requirements and promote patient safety throughout the product’s market life.