Product safety services

To limit your exposure to risk, we provide a team of highly qualified, experienced physicians and healthcare professionals focused on delivering expert pharmacovigilanceservices.

Our team offers end-to-end safety solutions covering the entire product lifecycle from development to post-marketing surveillance. We intelligently apply the latest technology innovations to extract optimum value from acquired safety data. We address evolving issues related to products and processes evaluating their safety. Our global delivery centers leverage the expertise of safety professionals familiar with requirements throughout the world to assist in developing your product wherever you choose to operate.

Whatever your requirement for product safety, Medilenz is a partner you can trust to deliver exceptional results and peace of mind.

Individual Case Safety Reporting (ICSR)Processing

We apply proven methodologies and industry-standard best practices through every stage of case management:

  • Indexing
  • Triage
  • Data entry
  • Quality review
  • Medical review
  • Submissions

At each of these stages, Medilenz professionals pay careful attention to established business metrics and workflow to ensure efficiency, accountability, and transparency. The result is high-quality safety data forming the basis for an accurate profile of your product's safety.

We offer a comprehensive range of case management services that can be tailored to meet your requirements and/or budget. Select only the services you require, or an end-to-end solution covering your entire development program, from the earliest phases of clinical trials to post-marketing surveillance.

Other services include:

  • Safety literature searches
  • E2B case reporting & archiving
  • Regulatory compliance & tracking
  • Safety data exchange agreement (SDEA) maintenance & tracking
  • Automated creation of follow-up letter & narration
  • Submission of serious reports to the regulatory authority
  • Quality assurance


We consistently have been able to deliver quality of more than 99% for case processing and < 0.5 errors per page for document authoring. Our singular focus is on getting our reviews "First TimeRight."


We have been able to consistently maintain the timelines at 100% year on year for case processing and for regulatory submissions. We have been able to achieve this as a result of a robust quality review and workflow tracking process, which enable us to deliver quality first-time documents and also helps us track and mitigate any risk toward the submission of the documents to the regulatory authority.


Our Intelligent Safety Suite is a unique offering which allows us to significantly automate and improve compliance and turnaround time for cases. This along with continuous improvement initiatives have led to boosting productivity gains for many of our customers by over 60%. Apart from automation, we have been able to achieve this as a result of continuous and nuanced training to our review specialists, deployment of trained subject matter experts, centralizing the operations of review processes, and contextualizing modern technologies to automate an increasingly significant portion of the review processes.


We have maintained a track record of 100% compliance on all our engagements not only for operational delivery but also for client training and process requirements. Our specialists have knowledge of global and regional regulations and guidelines. Our specialists are regularly and continuously trained on ever-changing regulatory policies. We also engage closely with key personnel who are or have been involved in constituting regulatory guidelines.

Medilenz has exceeded its client expectations through maintaining high-quality delivery as evident from zero critical findings in the audit and vendor assessments.

Medilenz is a pioneer and state of the art service provider in aggregate reporting

Medilenz 's aggregate reporting and safety documents authoring team comprises extensively experienced medical writers and healthcare professionals with deep medical knowledge and good understanding of global regulatory/safety practices. We have a successful track record of providing end-to-end support from managing global reporting calendar, sending for call for contributions and coordinating with contributors, authoring, medical and quality review, and formatting and submission readiness for a range of documents.

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

Our safety professionals offer a unique blend of knowledge regarding pharmacovigilance business processes, emerging regulatory requirements, and cutting-edge technology.

Medilenz has extensive medical expertise and sophisticated big-data analytics capabilities to offer services across signal identification, evaluation, categorization of identified and potential risk, and identifying needs for specific data collection. This solution combines evidence-based statistical results, with experience-based physician monitoring to help decipher a drug's clinical behavior and detect signals related to its safety and interactions with other factors.

Medilenz has extensive data-mining expertise across FDA AERS, clinical trials, and other data sets and time series analysis, along with automated analyses for aggregate data review for heightened surveillance products with open signals. Specialized analytics, customized thresholds, trending, workflow, as well as built-in comparison engines (risk groups, time period, drug, etc.) provide a robust product-specific signaling and surveillance framework to our clients, which may include:

  • Signal detection from various sources - PV safety database, regulatory database, LPs, company studies, published and unpublished medical literature, preclinical studies, product complaint information, and so on
  • Line-listings assessment from the safety database for D-E pair analysis
  • Detection, prioritization, validation, and evaluation of safety signals using qualitative and quantitative methods and algorithms for routine and heightened surveillance (PRR, ROR, Chi-square, Bayesian methods of statistical analysis, etc.)
  • Signal report preparation for signal review committee

We work with our clients to define a proactive risk management strategy and robust business process to execute that strategy. The IT portion of our strategy incorporates the current state-of-the-art in data mining, analysis, and information delivery.

To ensure accurate assessment of safety signals, Medilenz provides detection and analysis throughout the signal's lifecycle, and makes prompt recommendations on findings and need for additional analyses.

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

Labeling services

Medilenz resources are proficient in local labeling of documents in accordance with CCDS guidelines, which include:

  • Registering a request
  • Confirmation on label changes and updates
  • Translation of Local Product/ Patient Labels
  • Assessment and approval
  • Scientific meeting services