Meeting global regulatory requirements for ICSRs—whether from spontaneous or solicited post-marketing sources, or clinical trials—can be challenging. At Oviya MedSafe, we provide a seamless, end-to-end case management solution. Our experienced team of physicians, scientists, pharmacists, and medical data managers ensures every stage of the ICSR lifecycle is handled with precision. From collecting safety data through medical information queries and literature searches, to assessing suspected adverse drug reactions (ADRs) and submitting timely, accurate reports to regulatory authorities, we prioritize compliance and efficiency. Our integrated approach guarantees adherence to global regulatory standards, safeguards patient safety, and supports timely reporting, giving you confidence in meeting all regulatory obligations across multiple jurisdictions. Whether for a small-scale clinical trial or global post-marketing surveillance, we ensure the highest quality standards in ICSR processing.

With increasing regulatory demands, organizations must ensure comprehensive evaluation of the benefit-risk balance of their products through aggregate reports. Oviya MedSafe provides expert support in preparing and reviewing key reports like Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Addendum to Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER), and Development Safety Update Report (DSUR). Our experienced team ensures these reports are accurate, compliant with ICH guidelines, aligned with the applicable regulatory requirements, and tailored to meet your specific needs. We focus on presenting safety data clearly and ensuring its integrity, so that regulators can assess the safety and benefit-risk profile effectively. By maintaining strict timelines, we help ensure timely submission to the appropriate regulatory authorities, supporting your ongoing compliance and safety monitoring efforts.

In compliance with European and UK regulatory requirements, having a Qualified Person Responsible for Pharmacovigilance (QPPV) and Local Responsible Person (LRP) is crucial for ensuring the proper oversight and management of Pharmacovigilance activities. Oviya MedSafe offers expert EU and UK QPPV services, providing comprehensive coverage for both regions. In addition, we offer Local Responsible Person (LRP) services, primarily for European markets, ensuring that your Pharmacovigilance system meets all local and regional regulatory standards.

Our experienced team can serve as your EU/UK QPPV, providing the necessary regulatory oversight and ensuring the continuous management of safety data. We support the timely submission of safety reports, the implementation of risk management strategies, and maintaining communication with regulatory agencies, while ensuring compliance with Good Pharmacovigilance Practices (GVP). Our QPPV and LRP services are tailored to meet your specific needs, helping you maintain regulatory compliance and safeguard patient safety throughout the product lifecycle.

Risk management is essential to regulatory compliance and safety assurance throughout a product's lifecycle. In the European Union, every new medicinal product requires a Risk Management Plan (RMP) to assess and minimize risks. At Oviya MedSafe, we support the creation of comprehensive RMPs that proactively identify, communicate, and manage risks, ensuring that the benefit-risk balance is continuously monitored and optimized.

In addition to RMPs, in the United States, the FDA mandates Risk Evaluation and Mitigation Strategies (REMS) for certain products. We assist in developing REMS, including Elements to Assure Safe Use (ETASU), designed to mitigate risks and ensure strict adherence to product labeling.

Our services extend to ROW regions and India, where RMPs are also mandatory. We offer end-to-end solutions for RMPs and REMS, helping manufacturers comply with regulatory commitments for risk assessment, minimization, and post-approval safety monitoring, ensuring continuous safety oversight in line with global regulatory standards.

Literature monitoring is a vital component of Pharmacovigilance, enabling the proactive identification of safety concerns from published medical and scientific reports. At Oviya MedSafe, we provide comprehensive global and local literature monitoring services, ensuring that all relevant safety information is reviewed thoroughly to identify potential adverse effects.

Our approach is tailored to meet both global and local regulatory requirements, while maintaining a high level of quality and efficiency. By conducting systematic literature reviews, we ensure that any medical evidence suggesting adverse effects is carefully assessed. Our team of medical experts screens published reports from multiple sources, including medical journals, conference abstracts, and case reports, to identify safety signals and support informed decision-making.

Through this evidence-based process, we help our clients make timely, informed decisions, manage risks proactively, and ensure compliance with regulatory reporting requirements, safeguarding patient safety and enhancing regulatory compliance.

Signal detection is a critical process for identifying potential safety concerns and maintaining the safety profile of products throughout their lifecycle. At Oviya MedSafe, we use industry-recognized best practices, advanced data analytics, and our medical expertise to promptly detect, assess, and manage safety signals. Our structured approach ensures that any emerging risks are thoroughly evaluated, enabling the development of effective action plans to mitigate and manage those risks.

Our team ensures that the signal detection process complies with global Pharmacovigilance regulations, facilitating timely reporting to regulatory authorities when necessary. With a focus on regulatory compliance and evidence-based decisions, we support you in maintaining a robust Pharmacovigilance system that safeguards patient safety while meeting regulatory obligations.

Managing safety in clinical trials is a critical and complex task, and effective safety oversight is vital to maintaining compliance with regulatory requirements and ensuring patient safety. Oviya MedSafe provides a full range of Pharmacovigilance services to support clinical trials at every stage of their lifecycle, from early-phase trials to post-marketing surveillance.

We offer complete ICSR processing for clinical trial adverse events (AEs) and serious adverse events (SAEs), ensuring timely and accurate reporting. For sponsors who lack their own Pharmacovigilance database, we provide a secure and compliant PV database solution to manage safety data efficiently.

Our team is also equipped to prepare and implement Safety Management Plans tailored to your clinical trial needs, ensuring proactive management of potential risks. As part of our service, we prepare and submit essential reports such as Annual Safety Reports and Development Safety Update Reports (DSURs), in compliance with regulatory standards.

With Oviya MedSafe’s expertise, you can be confident that all safety aspects of your clinical trials are comprehensively managed and fully compliant with International regulations, safeguarding both patient safety and regulatory integrity throughout the trial lifecycle.