Our services encompass various aggregate reports, including Periodic Safety Update Reports (PSUR), Developmental Safety Update Reports (DSUR), and Periodic Adverse Drug Experience Reports (PADER), ensuring a comprehensive overview of drug safety profiles.

S2M provides robust support for Annual Safety Reports (ASR) and IND Annual Reports (IND), ensuring compliance with regulatory requirements and maintaining a proactive approach to drug safety.

Our team efficiently handles and reports adverse events during clinical trials, ensuring accurate documentation and adherence to regulatory guidelines.

S2M specializes in the triaging and management of post-marketing adverse drug reactions, prioritizing patient safety and regulatory compliance.

We offer comprehensive medical writing services, including narrative writing, expert statements, and investigator notifications, contributing to clear and concise documentation.

Our strength lies in our experienced team and robust IT infrastructure. We house a highly scalable global delivery model and comply with regulatory standards, including 21 CFR (Part 11) and Eudra Vigilance.

S2M conducts signal detection and evaluation, proactively identifying potential safety concerns and taking necessary actions to ensure patient welfare.

Our Unique Selling Proposition (USP) revolves around delivering high-quality, customized services within specified timelines. We integrate technology and processes, ensuring efficient data management and compliance with emerging regulatory standards.

S2M excels in seamlessly integrating and managing data in accordance with standard regulatory guidelines. Our approach ensures data accuracy, compliance, and efficiency in pharmacovigilance processes.

We facilitate electronic submissions of reports to regulators through an electronic gateway, streamlining the regulatory compliance process and ensuring timely communication.

S2M integrates our work with a robust operations team, ensuring backup support, generating status reports, and implementing new processes to meet evolving project requirements.