Provaxa
Pharmacovigilance
Guarding Health Through Vigilance
Comprehensive safety monitoring and risk management throughout the entire product lifecycle, from clinical development to post-marketing surveillance.
Pharmacovigilance Excellence
Integrated safety monitoring and risk management across the product lifecycle
Your Dedicated Safety Partner
Provaxa provides comprehensive pharmacovigilance services that systematically monitor, detect, assess, and prevent adverse drug reactions and related problems throughout a product's lifecycle. From clinical development through post-approval, we integrate data collection, risk assessment, and transparent communication to minimize risks while maximizing therapeutic benefits.
Our pharmacovigilance experts strengthen the understanding of drug safety, contributing to improved regulatory standards and enhanced patient care. We maintain ICH-GCP compliance, ISO-certified quality systems, and proven expertise navigating complex global regulatory environments.
We support pharmaceutical companies in maintaining compliance, enhancing drug safety, and accelerating regulatory approvals across CDSCO, EMA, US FDA, and other global pathways.
Why Pharmacovigilance Matters
Pharmacovigilance is integral to identifying, evaluating, and managing risks during clinical trials and post-approval. It enables early detection of adverse drug reactions (ADRs), ensures the balance of benefit versus risk is continually reassessed as new safety data emerges, facilitates compliance with regulatory requirements, and ultimately protects patient welfare while accelerating approval timelines.
Our Pharmacovigilance Services
Comprehensive safety solutions across the entire product lifecycle
Adverse Event & SAE Reporting
End-to-end management of adverse event (AE) and serious adverse event (SAE) collection, processing, and reporting. We ensure timely, accurate submissions to regulatory authorities while maintaining full compliance with safety reporting timelines.
- AE/SAE receipt and triage
- Follow-up assessment and data completeness
- SUSAR submissions (Suspected Unexpected Serious Adverse Reactions)
- Expedited reporting compliance
- Causality assessment
- Regulatory authority submissions
Signal Detection & Risk Management
Systematic identification and evaluation of new or emerging safety risks through advanced data analytics and rigorous scientific assessment. We develop comprehensive risk management plans (RMPs) and safety strategies tailored to your product's safety profile.
- Signal detection methodology & implementation
- Risk-benefit analysis
- Risk Management Plan (RMP) development
- Safety Specification documentation
- Pharmacovigilance Plan (PhVP) design
- Post-authorization Safety Studies
Safety Database & ICSR Management
Establishment, maintenance, and optimization of safety databases for complete AE/SAE tracking and Individual Case Safety Report (ICSR) management. Secure data storage, quality assurance, and regulatory audit readiness.
- Safety database setup & validation
- ICSR creation and coding (MedDRA)
- Case processing & follow-up
- Data quality assurance & audits
- Literature screening & evaluation
- Database backup & security
Periodic Safety & Regulatory Reports
Comprehensive preparation and submission of periodic safety update reports (PSURs), development safety update reports (DSURs), and annual safety reports. Full compliance with ICH guidelines and regional regulatory requirements.
- PSUR (Periodic Safety Update Report) preparation
- DSUR (Development Safety Update Report) compilation
- Annual Safety Reports & IB updates
- Safety Summary documentation
- Regulatory compliance verification
- Multi-regional submissions (CDSCO, EMA, FDA)
Safety Monitoring Committee Setup & Support
Establishment and operational support of independent Data Safety Monitoring Boards (DSMB) and Safety Monitoring Committees. We provide meeting coordination, safety reports, risk assessment documentation, and regulatory compliance.
- DSMB/SMC charter development
- Committee member identification & engagement
- Safety briefing package preparation
- Meeting logistics & documentation
- Safety recommendations implementation
- Committee communication management
Pharmacovigilance System Master File (PSMF)
Development, maintenance, and updates of comprehensive Pharmacovigilance System Master Files. Complete documentation of your pharmacovigilance systems, processes, and quality assurance measures for regulatory submissions and inspections.
- PSMF creation & documentation
- Pharmacovigilance system description
- Quality Overall Summary (QOS)
- Standard Operating Procedures (SOPs)
- Organizational chart & responsibilities
- Annual PSMF updates & audit readiness
Regulatory Expertise & Compliance
Deep knowledge and proven track record across global regulatory requirements
Global Regulatory Leadership
Provaxa maintains comprehensive expertise in pharmacovigilance requirements across all major global regulatory authorities. Our team has extensive experience navigating CDSCO (Central Drugs Standard Control Organisation), EMA (European Medicines Agency), US FDA (Food and Drug Administration), and other regional regulatory pathways.
We understand the nuanced differences in pharmacovigilance expectations across jurisdictions and ensure your safety monitoring strategies align with each region's specific requirements. Our proactive regulatory engagement helps sponsors anticipate requirements, streamline submissions, and accelerate approval timelines.
Key Regulatory Focus Areas:
- ICH-GCP (International Council for Harmonisation - Good Clinical Practice) compliance
- EMA guidelines for Pharmacovigilance (Guideline on Pharmacovigilance for Medicinal Products)
- US FDA regulations (Title 21 CFR Part 312 and 314)
- CDSCO requirements for clinical trial and post-approval safety reporting
- ISO 14971 Risk Management standards
- Multi-regional harmonization and strategic regulatory planning
Compliance Assurance
Our ISO-certified quality systems and proven compliance record ensure your pharmacovigilance program meets all regulatory expectations. We maintain detailed audit trails, comprehensive documentation, and robust quality control measures to support regulatory inspections and submissions with confidence.
Protect Patient Safety, Accelerate Regulatory Success
Partner with Provaxa for comprehensive pharmacovigilance services that ensure drug safety, regulatory compliance, and patient-focused outcomes throughout your product's lifecycle.