Enhancing efficiency by streamlining workflows and strengthening compliance through targeted gap resolution.
Implementing robust management practices and ensuring reliable partnerships through thorough assessment and qualification.
Proven capability in executing projects seamlessly across global markets with regional insights.
Structured frameworks ensure efficiency, consistency, and on-time delivery.
Subject matter experts bring deep scientific understanding to every project.
Compliance-driven operations designed to meet the highest regulatory standards at all times.
Proactive identification and mitigation strategies ensure smooth project execution.
Optimised workflows and resource utilisation deliver measurable cost efficiencies.
End-to-end pharmacovigilance solutions to ensure patient safety and
regulatory compliance.
ICSR Case Processing
Aggregate Reporting
Signal Management
Risk Management & Minimisation Support
PV Regulatory Intelligence
Safety Database Management
PSMF & SDEA Management
xEVMPD Support
REMS Management
Medical Complaints
MICC Support
Social Media Monitoring
Delivering accurate and efficient case processing solutions from intake to regulatory submission.
Case Evaluation Case Booking Triage & Case prioritisation Data Entry Coding (WHO DD and MedDRA) Labelling Seriousness Narrative writing Medical Review Causality Assessment Case comment Health Authorities submission & Acknowledgement
Enabling proactive detection, evaluation, and management of safety signals to safeguard patient well-being.
Product Strategy Medical Concepts AE grouping (DME, TME and EBGM / Statistical outputs) Review of data from clinical trials, electronic records (EHRs), and social media Real-time tracking and identification of safety signals Evaluation of emerging safety issues Medical review and analysis of signals Risk factor identification and review Trend analysis: Reporting rates based on drug exposure Data Mining using VigiBase, FAERS, EVDAS data Literature review and assessment Product safety review meetings Signal Validation Notification to Health Authorities Signal confirmation & prioritization Handling over 800+ product portfolios across all TAs Expertise in Qualitative and quantitative methods for signal detection Using signal detection tools like Empirica and statistical methods
Our Medical Information Contact Centre is dedicated to providing accurate and timely information to healthcare professionals, patients, and consumers.
Patient Support Medical Information Adverse Event Reporting Clinical Trial Support Product Quality Complaints Supporting Pharmaceutical, Medical Devices, and Cosmetics companies. Local and Global Regulatory Compliance. Global Coverage & 24/7 Support. Integrated Technology & Multi-lingual Support. Omni-channel Enablement Phone, Email, Chat, Social Media
Ensuring high-quality, compliant aggregate reports through robust processes and expert oversight.
Data Strategy Meeting Calendar Support & Maintenance Preliminary Case Listing Validated Case Listing Final source documents Review of all source documents –labels, cases, health authority requests Quality Review Incorporation of Comments AR Sign-off Final AR Review Business Partner / Local Market Approval Summary Preparation Submission to Health Authorities ArchivingDelivering 100% compliant PBRERs, RMPs, ACOs, CARs, PSURs, and PADERs across diverse therapeutic areas.
Strengthening product safety through strategic risk identification, assessment, and mitigation planning.
Epidemiological study summaries Literature Review Non-clinical, Clinical & post marketing safety sections Signal review Risk Assessment Reports Trend Analysis Mitigation plan based on Risk Assessment Reports Mitigation plan based on Health Hazard Evaluation Reports Identification of ETASU Identification and characterisation of safety concerns Planned PV actions -safety study, brochures, PIL preparation, label creation Post marketing surveillance plan Preparation of Risk Assessment Documents and matrices Proactive recommendations –Label changes, HCP communications & education, patient education, box warnings, controlled distributions, assisted administration, medication guide Review and update of RMPs / REMs / BREs
Conducting systematic literature monitoring to identify safety insights and support regulatory compliance.
Literature database: PubMed, MEDLINE, EMBASE Local literature search strategy (Selection of Non-Indexed Journals) Compilation of search results and abstracts, Deduplication Review of Literature Hits and classification Case Creation/ Notification to the ICSR team Full text procurement Medical Relevance Potential Signal Identification Aggregate Report Inclusion Case Creation –ICSR Enhanced efficiency & output
We ensure clear, concise medical writing support from pre- to post-marketing product life cycle.
Protocol development Investigator's Brochures and Patient Leaflet Claims Management Clinical Study Reports (CSR) Manuscripts Complex Medical inquiries response preparation Aggregate reports and Risk Management Plans Clinical Evaluation Plan (CEP) Clinical Evaluation Reports (CER) Summary of Safety and Clinical Performance (SSCP) Post Marketing Surveillance Plan (PMS) PSURs Post-market clinical follow-up plans (PMCFP)![[object Object]](/_next/image?url=%2F_next%2Fstatic%2Fmedia%2FNovaVigil-banner.0chf-hpkvx~_-.webp&w=3840&q=75)
Pivot Path delivers AI-powered literature surveillance through NovaVigil, our intelligent pharmacovigilance platform. NovaVigil streamlines literature monitoring and ICSR processing by automating article screening, data extraction, and case narrative generation while keeping expert reviewers in control of clinical decisions. By handling repetitive tasks and maintaining complete audit trails, it enables life sciences teams to meet regulatory timelines, scale case volumes without proportional headcount, and focus their expertise on patient safety rather than manual data entry.
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