Safety & Pharmacovigilance

Safety & Pharmacovigilance

At GAYA PHARMA, we recognize that ensuring patient safety and maintaining stringent regulatory compliance are paramount for any pharmaceutical company. That's why we offer a comprehensive suite of Safety and Pharmacovigilance services designed to help you navigate the complex landscape of safety reporting and regulatory requirements efficiently.

Our core pharmacovigilance support includes essential measures to ensure you stay fully compliant with all relevant regulations. These services encompass Adverse Event (AE) and Serious Adverse Event (SAE) reporting and management, meticulous literature review, effective signal detection, and accurate MedDRA coding. Furthermore, we provide critical support for regulatory inspections and help you expertly develop and implement a pharmacovigilance system tailored to your specific market needs.

We provide specialized monitoring services, such as ADR monitoring, which allows for the prompt detection, assessment, and understanding of any new safety information related to your products. We also perform AE/SAE severity determination; this crucial service involves evaluating and classifying the severity of reported events, ensuring accurate and timely reporting to regulatory agencies as required.

Ultimately, our safety and pharmacovigilance services go beyond mere compliance—they actively help you protect your patients by identifying and proactively managing safety risks. Our team of experts is skilled in assessing safety signals and assisting you in developing and implementing robust risk management strategies. Contact GAYA PHARMA today to learn more about how our expertise can secure your patient care and compliance efforts.