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Literature Monitoring
Services
Literature Monitoring from Clinical Development to Post-Market
Biologit specialises in providing literature monitoring services and expert consulting to meet global regulatory requirements, including those set forth by prominent authorities such as the European Medicines Agency (EMA), Food & Drug Administration (FDA), Pharmaceuticals & Medical Device Agency (PDMA), Therapeutic Goods Administration (TGA), and more. Fuelled by the validated biologit MLM-AI platform, we are a partner for:
Clinical Development
Regulatory Affairs
Medical Affairs
Signal Management and Benefit-Risk Assessments
Systematic and proactive assessment of the literature to identify novel safety signals; preparation of regulatory submissions for signal management and benefit-risk assessments for Risk Management Plans (RMP).
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Individual Case Safety Reports (ICSR) for Medicines, Medical Devices and Cosmetics
Project planning, setup and execution of literature monitoring strategies for GVP compliant individual case safety reporting (ICSR); Clinical Evaluation Reports (CERs) and IVDR Performance Evaluation Reports (PERs) for medical devices in compliance with Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR); Cosmetics safety monitoring for Cosmetics Product Safety Report (CPSR).
Global and Local Literature Monitoring
Streamline all your monitoring needs with a single vendor, harnessing the comprehensive coverage of the biologit Database to fulfill both global and local literature requirements seamlessly. Our simplified, multi-lingual, and unified process spans across the Americas, Europe, Africa, Oceania, and Asia.
Aggregate Reports
Systematic safety information literature reviews for regulatory reporting: Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Development Safety Update Report (DSUR), ad-hoc reports in response to safety queries from regulatory authorities.
Clinical Development
Project setup and execution of literature search meeting clinical development FDA regulatory requirements; literature search support for ICH GCP clinical development reports, i.e. Investigator Brochure - IB and Clinical Study Protocol.
Medical and Regulatory Affairs
We provide literature search and review support for Investigational New Drug (IND) applications, Biologics License Applications (BLA), New Drug Applications (NDA), Marketing Authorisation Applications (MAA), and Clinical Trials Applications (CTA).
~ Service Provider, USA
“Innovative, easy to work with, good support”
~ Pharma, Ireland
“Professional, User-friendly, and supportive”
