Individual Case Safety Reporting Processing (ICSR):
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.
Adverse event reporting and safety assessment reporting:
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.
Our skilled writers have experience in:
Drafting end-to-end PSURs/PBRERs and PADERs for legacy products and new molecules
Drafting end-to-end line listing reports, addendum, safety summaries, clinical overviews, bi-monthly reporting of SASUSARs and summary bridging reports
Drafting PADER waivers and Russian renewals
Documentation of commitments made to health authority in company trackers
Drafting appendix 4 for DSUR and supporting other sections
Signal Detection Services
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.
XEVMPD Management Services
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.
Regulatory Authority Site Search (RASS)
Medilenz Innovations is a pioneer and state of the art service provider in RASS services.
Our process include:
RASS is performed on a regular basis for each active moiety or INN
Submitted to the following Regulatory Authorities: USFDA, EMA, HMA, MHRA, LAREB, DMA and other applicable regulatory authorities
Findings/Recommendation to be assessed with the company approved labeling documents
Recommending variations which are in-line with the innovator labeling document/authority recommendation
Literature review services to detect signals and/or identify trends
Medilenz team is highly skilled in literature review services.
Our literature review services mainly include, but are not limited to the following:
Searching in the medical databases for AEs and /or Safety Signals for the MA products
Searches are conducted for each active moiety or INN
Valid ICSRs identified will be databased and reported accordingly to applicable regulatory authorities
Follow-up with authors will be conducted, if required
Safety Signals will be assessed and will be recommended for updating labeling
Company Core Data Sheet And Company Core Safety Information (Ccds/Ccsi) Services
Medilenz has a team of experienced medical professionals that focuses on:
Producing Company Core Data Sheets (CCDS's), including Company Core Safety Information for new and stable or mature products
Setting up a Company Core Data Sheet tracking mechanism for future CCDS updates
Creating a draft CCDS with respect to Local Label Gap analysis to identify the need for supporting rationales/documentation for regulatory submission
Drafting supporting rationale and expert statements for finalization by the Client's in-house experts, including collection and collation of supporting documents; ordering submission quality copies of publications
Preparing comparisons between final draft CCDS and comparator labeling
In the framework of an ongoing project, providing CCDS/CCSI-related expertise and if required, contributing to the Client's review and decision-making discussions
If requested, use of templates for CCDS and CCDS Log, and CCDS Manual (detailed guidance on CCDS section content)
Service for Non-English translation with the certified translators
Medilenz resources are proficient in local labeling of documents in accordance with CCDS guidelines, which include: