PharmXL provides 24/7/365 adverse event management and reporting services to comply with regulatory timeline. Adverse event case processing from different sources i.e. clinical trial, literature, spontaneous, marketing program, call canter, health authority and various licensee parties in the pharmacovigilance database. Further, manage the reportability based on the seriousness and expectedness of adverse events.
Our team is expertise to assess safety data to identify the new safety signals and develop robust risk management plans (RMPs) to healthcare products. Our signal detection program consists following approach.
PharmXL provides strategic advice and analysis on risk managements begin with assessment and identification of potential risks associated with a product. On the basis of identified risk we develop risk minimization plan in collaboration with clients. Our team proactively review and helps the clients to monitor and minimise the risk profile of product to deliver the greater patient safety. We develops risk evaluation and mitigation strategies (REMS) and REMS update reports for USA; and compiles, writes and updates risk management plans (RMPs) for Europe/Asia.
PharmXL, offers comprehensive worldwide adverse event literature screening services for all types of products by using appropriate terms. It includes:
PharmXL reports writing experts ensures that periodic reports, risk assessment documents and safety update reports are prepared in the proper format with appropriate content and submitted to the relevant regulatory authorities as per timelines via electronic or printed version. Our dedicated healthcare team committed to generate quality and consistent reports in order to provide greater patient safety. We prepared following reports and submitted to relevant regulators.
Global periodic safety reporting (PADER, PSUR/PBRER)
Clinical periodic reports – IND/NDA annual reports and developmental safety update reports (DSURs).
Our team is expertise to assess safety data to identify the new safety signals and develop robust risk management plans (RMPs) to healthcare products. Our signal detection program consists following approach.
