Comprehensive Pharmacovigilance & Drug Safety Solutions
Thorough collection and assessment of product safety information is essential to the success of both clinical research studies and in maintaining post-marketing product licenses. At SN SCORT, our pharmacovigilance team integrates all safety services into a streamlined, transparent delivery model — combining advanced monitoring capabilities with regulatory expertise and a steadfast commitment to patient safety, regulatory compliance, and scientific excellence.
Adverse Event (AE) & Serious Adverse Event (SAE) Management
Our pharmacovigilance team provides end-to-end adverse event management including receipt, triage, medical review, causality assessment, narrative writing, and regulatory submissions. We ensure timely and accurate SAE reporting to sponsors, CROs, Ethics Committees, and regulatory authorities in compliance with ICH E2A, CDSCO, and NDCT Rules timelines.
Our case processing capabilities cover ICSRs for both investigational and marketed products, with a focus on data accuracy, audit-readiness, and regulatory compliance at every step.
Learn moreSafety Monitoring & Signal Detection
Our safety monitoring services employ systematic review and analysis of safety data to detect emerging signals early. We apply quantitative and qualitative signal detection methodologies aligned with ICH E2E and GPVP guidelines, enabling proactive risk identification and management across investigational and marketed products.
Regular safety monitoring reviews, trend analyses, and benefit-risk evaluations are conducted to support informed decision-making for sponsors and investigators throughout the clinical development lifecycle.
Learn moreLiterature Monitoring & Review
SN SCORT provides systematic global and local literature monitoring services across key scientific databases to identify published reports of adverse events, safety signals, and emerging safety information relevant to your product.
Our team conducts routine monitoring and focused literature reviews to support aggregate reporting, signal management, and regulatory submissions. Local literature surveillance ensures compliance with regional pharmacovigilance requirements including CDSCO and international guidelines.
Learn moreAggregate Safety Reporting
PSUR · PBRER · DSUR · SUSAR Line ListingsOur medical writing and pharmacovigilance teams collaborate to produce high-quality aggregate safety reports including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and SUSAR line listings in accordance with ICH E2C, ICH E2F, and applicable national regulatory requirements.
We ensure timely, compliant submission of all periodic safety reports to regulatory authorities, Ethics Committees, and data safety monitoring boards.
Learn moreRisk Management Planning
SN SCORT supports the development and implementation of Risk Management Plans (RMPs) and Risk Minimisation Measures aligned with EMA, CDSCO, and international regulatory requirements. Our team assists sponsors in identifying, characterising, and communicating product risks to regulators, healthcare professionals, and patients.
We also provide support for the development of patient information materials, healthcare professional communications, and additional risk minimisation activities as required by regulatory agencies.
Learn morePharmacovigilance System Setup & Audit Support
We assist sponsors and investigators in establishing and maintaining a robust pharmacovigilance system, including the preparation of the Pharmacovigilance System Master File (PSMF), Standard Operating Procedures (SOPs), safety database configuration, and staff training programmes aligned with GPVP and ICH-GCP requirements.
SN SCORT also supports pharmacovigilance audits, regulatory inspections, and CAPA management, ensuring your organisation is inspection-ready at all times.
Learn morePost-Marketing Pharmacovigilance
Our dedicated post-marketing pharmacovigilance services cover the full spectrum of safety activities for marketed products, including spontaneous adverse event case processing, signal detection and evaluation, PSUR/PBRER preparation, literature monitoring, risk management, and regulatory intelligence.
We understand the regulatory landscape in India and internationally, providing end-to-end support to ensure your product's safety profile is continuously monitored and managed throughout its commercial lifecycle in compliance with CDSCO and applicable global requirements.
Learn moreMedical Device Vigilance
SN SCORT provides specialised vigilance services for medical devices including adverse incident reporting, field safety corrective actions, periodic safety reports, and regulatory submissions to CDSCO and other competent authorities in accordance with the Medical Devices Rules, 2017 and applicable ISO standards.
Our device vigilance team works closely with manufacturers, sponsors, and investigators to ensure timely and compliant management of device-related safety events throughout the product lifecycle.
Learn morePharmacovigilance for Biotech & Emerging Companies
We recognise that biotech and small to mid-sized companies have unique needs. Our flexible, scalable, and cost-effective pharmacovigilance solutions are tailored to your stage of development, ensuring you receive expert safety management support without the overhead of a large internal team.
Learn moreNutraceutical & Herbal Product Safety Monitoring
SN SCORT offers specialised pharmacovigilance and safety monitoring services for nutraceutical and herbal products, supporting adverse event collection, medical review, and regulatory reporting in line with applicable FSSAI and CDSCO guidelines.
Learn moreScalable & Fully Customisable Service Models
Our pharmacovigilance operating models are fully flexible — available as standalone consulting support, functional service provision, or full end-to-end outsourcing. We work with sponsor systems, our own internal infrastructure, or a combined approach across all therapeutic areas and product types.
Every engagement is assigned a dedicated pharmacovigilance lead ensuring consistent delivery, clear KPIs, and transparent reporting throughout the project lifecycle.
Robust Quality & Documentation Systems
All pharmacovigilance activities at SN SCORT are governed by a comprehensive library of SOPs and work instructions aligned with GPVP, ICH-GCP, CDSCO guidelines, and the NDCT Rules 2019. We maintain rigorous documentation standards, regular quality reviews, and proactive CAPA management to ensure the highest levels of data integrity and regulatory compliance.
Our quality commitment extends to staff training, process audits, and continuous improvement initiatives that safeguard the integrity of every project we undertake.