Pharmacovigilance & Drug Safety Services
At Tactus Lifesciences, patient safety and regulatory compliance are at the heart of everything we do. Our comprehensive Pharmacovigilance (PV) and Drug Safety services help pharmaceutical, biotechnology, and medical device companies navigate complex global regulations while ensuring the highest standards of product safety and risk management. From early-phase clinical trials to post-marketing surveillance, we provide end-to-end PV solutions, helping clients monitor, evaluate, and manage the safety profile of their products throughout the entire lifecycle.
With our robust PV infrastructure and experienced team of drug safety professionals, we ensure that your products meet stringent regulatory requirements in the EU, UK, US, and other global markets. By integrating signal detection, risk management, and regulatory reporting, Tactus Lifesciences supports companies in protecting patients, maintaining compliance, and optimizing the benefit-risk profile of their therapies.
Our Pharmacovigilance Services
Case Management & Safety Reporting
We provide comprehensive case processing and safety reporting services, ensuring timely, accurate, and compliant handling of all safety data:
- End-to-end processing of Individual Case Safety Reports (ICSRs)
- SAE / SUSAR reporting during clinical trials and post-marketing
- MedDRA / WHO coding, narrative writing, and medical review
- Literature monitoring and case extraction
- Regulatory submissions compliant with E2B (R3) standards
Aggregate & Periodic Safety Reports
Our experts prepare all required aggregate safety reports to meet regulatory obligations:
- Preparation and submission of PSURs / PBRERs / PADERs
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs) and region-specific formats
- Cumulative benefit-risk assessment and recommendations
Signal Detection & Risk Management
We proactively manage product safety through signal detection and risk management:
- Signal detection, analysis, and evaluation
- Risk Management Plans (RMPs) and REMS strategy development
- Continuous benefit-risk monitoring
- Safety labeling updates and communication with stakeholders
Regulatory Compliance & QPPV / RPPV Services
Our PV services ensure compliance and authorized oversight through QPPV / RPPV support:
- Acting as Qualified Person for Pharmacovigilance (QPPV) / Responsible Person for Pharmacovigilance (RPPV)
- Creation and maintenance of Pharmacovigilance System Master Files (PSMFs)
- Drafting and oversight of Safety Data Exchange Agreements (SDEAs)
- SOP development, workflow optimization, and process standardization
- Inspection and audit readiness, including mock audits
Consulting & Specialized PV Support
We offer strategic and customized PV consulting to enhance your systems and operations:
- PV gap analysis and compliance strategy development
- End-to-end PV system setup for global and local companies
- Training programs for clinical investigators and internal teams
- Medical information services and safety query handling
- Strategic guidance for market expansion and local PV compliance
Technology-Driven PV Solutions
We leverage advanced technology to streamline pharmacovigilance operations:
- Electronic safety databases for efficient case management
- Automated workflows for regulatory submissions and reporting
- Advanced analytics for signal detection and risk assessment
- Cloud-based platforms ensuring secure data management and accessibility
- Integration with global regulatory systems for seamless compliance and reporting
Our Clients
