Safety Data Collection & Triage
Pharmacovigilance & Regulatory Affairs
Ensuring Drug Safety & Regulatory Excellence
Our Innovative PV Solutions ensure drug safety and regulatory compliance with end-to-end case management solutions, risk and signal management, scientific writing services, and Europe-based QPPV services.
We help companies be future-ready with transformative consulting solutions and advanced tool offerings, ensuring comprehensive pharmacovigilance throughout the product lifecycle.
Case Management
Comprehensive adverse event handling (ICSR, SAE/SUSAR management), literature reviews, PV data migration, medical reviews, and PV agreement management.
Risk & Signal Management
Signal detection, benefit-risk assessments, US-REMS (Risk Evaluation and Mitigation Strategies), and comprehensive health inquiry responses.
Scientific Writing Services
Clinical Study Reports (CSR), protocols, regulatory submissions (Common Technical Document), and patient-facing materials including Informed Consent forms.
Europe/UK Based Services
Tailored regulatory compliance with PV audits, QPPV services, and EU-specific systems (Eudravigilance, PEMF) setup and maintenance for seamless compliance.
Our Coverage
Global Access Through
Panel
+ Tailored Recruitment
Healthcare Panel
1.11+ Mn
HCP's, Patients, Caregivers
Consumer Panel
1.75+ Mn
members associated across globe
B2B Panel
1.14+ Mn
Subject Matter Experts, Decision Makers, and Industry Leaders
Countries
50+Coverage
Languages
10+languages
Our Expertise
Key Services and Functions
Comprehensive pharmacovigilance (PV) and clinical research services organized into five main categories to ensure complete drug safety and regulatory compliance.
Case Management
Comprehensive adverse event handling (ICSR, SAE/SUSAR management), literature reviews, PV data migration, medical reviews, and PV agreement management.
ICSR Processing
SAE/SUSAR Management
Literature Monitoring
Scientific Writing Services
Clinical research documentation including Clinical Study Reports (CSR), protocols, regulatory submissions (Common Technical Document), and patient-facing materials.
Clinical Study Reports
Regulatory Submissions
Informed Consent Forms
Risk & Signal Management
Signal detection, benefit-risk assessments, US-REMS (Risk Evaluation and Mitigation Strategies), and comprehensive health inquiry responses.
Signal Detection
Benefit-Risk Analysis
US-REMS
Europe/UK Based Services
Tailored regulatory compliance with PV audits, QPPV services, and EU-specific systems (Eudravigilance, PEMF) setup and maintenance for seamless compliance.
QPPV Services
Eudravigilance
PV Audits
Consulting & Strategy
Strategic PV process optimization, regulatory intelligence, automation solutions, and innovative product/database offerings for future-ready operations.
Process Optimization
Regulatory Intelligence
Automation Solutions
Our Approach
Comprehensive PV Lifecycle Management
Our proven pharmacovigilance methodology ensures complete drug safety monitoring throughout the product lifecycle with systematic processes and regulatory excellence.
Case Processing & Medical Review
Regulatory Submission & Compliance
Signal Detection & Analysis
Risk Management & Mitigation
Continuous Quality Monitoring
Success Story
Delivering Excellence in Pharmacovigilance
A leading pharmaceutical company partnered with SPER to implement comprehensive pharmacovigilance systems, managing over 10,000 safety cases annually across 50+ countries with 100% regulatory compliance.
10,000+
Safety cases processed annually with quality excellence
50+
Countries covered with local regulatory expertise
100%
Regulatory compliance across all submissions
24/7
Continuous safety monitoring and support
Get Started
Ready to Enhance Your PV Operations?
Connect with our pharmacovigilance experts to discover how our comprehensive solutions can ensure drug safety and regulatory compliance for your organization.
Request a ConsultationFAQ
Frequently Asked Questions
Everything you need to know about our pharmacovigilance and regulatory affairs services.
Pharmacovigilance is the science of monitoring, detecting, assessing, and preventing adverse effects of pharmaceutical products. It's crucial for ensuring patient safety, maintaining regulatory compliance, and supporting informed decision-making throughout a drug's lifecycle.
We offer comprehensive PV services including case management (ICSR, SAE/SUSAR processing), signal detection and risk management, scientific writing, regulatory submissions, literature monitoring, PV system setup, QPPV services, and PV audits across global markets.
Yes, we provide specialized EU/UK services including QPPV (Qualified Person for Pharmacovigilance) services, Eudravigilance system management, PEMF (Pharmacovigilance Enquiry and Maintenance Form) support, and EU regulatory compliance consulting.
We implement robust quality management systems with multiple review stages, standardized SOPs, regular audits, continuous training programs, and advanced automation tools. All processes comply with ICH-GCP, FDA, EMA, and other global regulatory requirements.
We adhere to strict regulatory timelines: serious cases within 15 calendar days for initial reporting, expedited reports within 7 days for fatal/life-threatening cases, and follow-up reports as per regulatory requirements. We offer 24/7 support for urgent cases.
Simply request a consultation through our website or contact our PV team directly. We'll assess your requirements, discuss your PV needs, regulatory obligations, and provide a tailored solution with transparent pricing and implementation timelines.
