Medilenz has the experienced medical team that focuses on Case Intake, Case Processing, Medical Review, Safety Reporting, and Literature Search/Safety Searches. We have proficiency and regulatory knowledge in handling drug safety tasks associated with indications such as diabetes, hypertension, hematology and oncology. Medilenz team is excellent in consistent data capturing, timely reporting and analyzing the data.
Medilenz reviews relevant safety literature to ensure diligent product case management and reporting. Our medical team has expertise in emerging regulatory requirements and is actively involved in proactive risk management strategy and a robust business process for adverse events reporting. We conduct periodic literature search and review of articles, manuscripts, bibliographic searches for Individual Case Safety Reports (ICSR), Risk Management Analysis, PSURs / PBRERs.
We have a team of experienced professionals who can draft RMPs/REMs and assessments, Integrated Summary of Safety Sections (ISS) and Product Specific Pharmacovigilance plans applicable to RMP.
Medilenz is a pioneer and state of the art service provider in aggregate reporting. Our resources have extensive experience in drafting end-to-end PSURs, PADERs, PBRERs, clinical overviews and safety summaries.
MEDILENZ provides end-to-end solutions for risk management and signal detection needs. We work with our clients to define a proactive risk management strategy. We guide our customers in selecting the most appropriate technological solution to meet the business needs. MEDILENZ assists companies in adopting a formal signaling methodology that incorporates all relevant data sources in order to better understand the risk-benefit ratio of a product, and discover product adverse event relationships. This is now required by law in Europe (Volume 9A) and by guidance in the US (FDA Good PV Practices and Pharmacoepidemiology guidance). MEDILENZ's proactive signal detection services allow life sciences organizations to rapidly, and effectively identify potential risks and maintain compliance.
Medilenz has expertise in providing XEVMPD management services. We offer best-in-class XEVMPD solutions and services to efficiently handle the complete XEVMPD "Life Cycle Management" for the entire re-submission of medicinal product data to XEVMPD based on the level of readiness. We support XEVMPD submission for new MAH holders, updating XEVMPD data as per any amendments to MAH data, transition maintenance submission processes until the implementation of the International Standards on Identification of Medicinal Product (i.e. ISO IDMP standards) in 2016. Our comprehensive services suite helps organizations Collect, Collate, Convert the data into XEVPRM, and submit using the EVWEB tool, assuring an EMA-compliant output as per the new mandate.
Medilenz Innovations is a pioneer and state of the art service provider in RASS services.
Medilenz team is highly skilled in literature review services.
Medilenz resources are proficient in local labeling of documents in accordance with CCDS guidelines, which include: