Pharmacovigilance Technology. Built by SMEs. For the Real World.
Pharmacovigilance Technology. Built by SMEs. For the Real World.
ANSA: APCER's Technology Ecosystem
ANSA is APCER's proprietary technology ecosystem, built for the unique demands of regulated life sciences environments.
ANSA PV, the first suite within the ANSA ecosystem, brings together connected pharmacovigilance solutions designed by practitioners who understand the realities of safety operations. Developed through years of operational experience, every solution combines domain expertise, regulatory insight, and practical execution to help teams work more efficiently and confidently.
Compliance, security, and inspection readiness are embedded throughout the ecosystem. ANSA solutions align with global regulatory and industry standards, including 21 CFR Part 11, EU Annex 11, E2B(R3), HIPAA, GAMP 5 validation principles, ISO/IEC 27001:2022, and OWASP security practices—supporting the highest levels of quality, data integrity, and trust.
Whether deployed as a unified ecosystem or integrated into your existing technology landscape, ANSA's open architecture and API-driven interoperability enable seamless connectivity, end-to-end visibility, and scalable operations—without the disruption of replacing established systems.
Technology designed around the way your teams work—simplifying complexity, strengthening compliance, and enabling better decisions.
Benefits of Choosing APCER’s Technology Solutions
Operational Efficiency
Operational Efficiency
Reduce manual effort and eliminate fragmented workflows
Regulatory Confidence
Regulatory Confidence
Inspection-ready systems with full traceability
Lower Total Cost of Ownership
Lower Total Cost of Ownership
Fewer systems. Less integration. More control.
Future-Ready Architecture
Future-Ready Architecture
Adaptable to evolving regulatory and operational needs
Built for Today. Ready for Tomorrow.
Built for Today. Ready for Tomorrow.
Designed for where the industry is heading, delivered for where you are now.
APCER’s AI-powered PV Technology Offerings
- Case Intake and Processing ANSA PV SafetyFlow is a proven, production grade system, already processing thousands of cases; with speed and precision. Our platform automates intake from both structured and unstructured sources, using AI driven data extraction to produce E2B(R3) compliant output. Every case benefits from human in the loop review, validation, and physician oversight, ensuring high accuracy across diverse and complex source documents. The system is database agnostic, integrating seamlessly with your existing safety database. Outcome: Faster processing without compromising quality.
- Literature Screening ANSA PV LitSense enables accelerated, traceable literature screening that reduces effort while preserving full scientific oversight. Our solution covers everything from initial screening to full text review. AI assisted classification and screening handles growing literature volumes at scale, with bulk ingestion capabilities and one click ICSR upload. Full traceability and SME oversight are maintained throughout, giving you precision and control without the manual burden.
- Global Safety Database ANSA PV SafetyCore is our next generation proprietary safety database that brings everything together. Our database integrates case intake and literature surveillance into a single platform, designed for fast adoption. It is fully interoperable with your existing systems. One Platform. Reduced Complexity. Full Control.
- REMS/aRMM Web Application ANSA PV REMSConnect provides a single platform for every REMS or aRMM program. A flexible, configurable system supporting complex risk management programs worldwide. The platform delivers stakeholder management and training, real time dashboards and compliance tracking, and configurable workflows that are easily customizable for specific program requirements. The architecture is future ready, aligned with HL7 FHIR CodeX standards.
Explore Technology Developed by PV Experts for You
Meet Our Experts
Gaurav Shah
PhD, MBA
VP and Head - Information Technology
Pranav Dalal
PhD, MBA, B.E.
Associate Vice President - Information Technology
Real Results. Real Trust.
Real Stories
Sincerely thank you for all the effort, thoroughness and professionalism that went through conducting and reporting on this FDA PADER Gap Analysis as we now embark on our journey towards documentation and process improvement to ensure readiness for an actual inspection.
Director, Drug Safety and Medical Information
Canada-based global pharma
The APCER Pharmacovigilance team demonstrated exceptional collaboration and inspection readiness during FDA PADE Inspection. The accuracy, consistency, and completeness of expedited reports, reconciliations, and aggregate safety documentation clearly reflected strong teamwork and compliance across all deliverables.
VP, Regulatory and Quality
US-based biopharma
With all the transformation and rapid growth happening, having a reliable PV/med info partner like the APCER group has truly been invaluable—it’s made a real difference in helping us navigate the complexities and keep challenges to a minimum.
VP, Medical Affairs
US-based specialty pharma
... the preparation and support for our BPD Type 2a meeting were a strong example of APCER’s commitment and effectiveness and instrumental in keeping us aligned and confident in our regulatory strategy. We have greatly valued the team’s responsiveness, collaborative approach, and sound regulatory judgment.
Chief Medical Officer
A clinical-stage biopharma
Phase 1 completion is an achievement that demonstrates APCER's scalability, flexibility, and operational readiness. It reflects exceptional cross-functional collaboration.
Associate Director, IT Business Partner
Japan-headquartered, global healthcare company
I want to sincerely appreciate all the great work Team APCER has been doing. Their strong attention to detail, agility in handling tasks, and consistent respect for timelines have been truly impressive.
Associate Director, Safety Physician
Japan-headquartered, global healthcare company
Deep gratitude to entire APCER team for their efforts in working hard to complete the cases. While the system outage was well beyond their control, their strong work to make up for the lost time ensured that we're able to maintain compliance.
Associate Director, Pharmacovigilance Operations
US-based biotech
Sincere appreciation for APCER's partnership and dedicated service. The team’s commitment, adaptability, and collaborative approach have been instrumental in supporting our pharmacovigilance operations through both high and low volumes of activity.
Sr.Director, PV Operations-Global Case Management
US-based biotech
I’ve greatly valued APCER’s commitment to excellence. Their contributions have played a key role in helping us uphold our compliance standards and achieve strong performance across key metrics, including timely deviation closure, audit readiness, and quality of deliverables.
Sr. Director PV Ops – Pharmacovigilance Center of Excellence
US-based biotech
