Pharmacovigilance Services: Built for Scale, Proven in Compliance
Pharmacovigilance that's Designed to
Support Growth, Manage Complexity, and Strengthen Compliance
Our pharmacovigilance solutions evolve with your requirements, supporting expansion into new markets, integration of new products, and managing increasingly complex regulatory expectations. From strengthening systems ahead of inspections to stabilizing and enhancing existing PV frameworks, we ensure continuity, compliance, and operational clarity at every stage. Whether navigating M&A transitions, entering new geographies, or addressing heightened regulatory scrutiny, we partner with you to build resilient pharmacovigilance systems that protect both your products and your reputation.
Together for Better Health:
By the Numbers
Built by Industry Experts.
Designed for Safety.
Delivered with Precision.
Pharmacovigilance Expertise
That Delivers Real Results
Case Study
A US oncology biotech expanded rapidly while maintaining compliance and inspection readiness through APCER's scalable pharmacovigilance support.
Case Study
A global pharmaceutical company navigated migrations, inspections, and partner complexity while maintaining compliance through APCER's unwavering support.
Case Study
APCER rapidly expanded capacity over a few months, enabling a pharmaceutical company to transition substantial case volumes while achieving high quality and compliance.
Case Study
A US oncology biotech enhanced clinical trial safety data mangement, regulatory compliance, and operational oversight through APCER's transition and PV expertise.
Case Study
Following multiple acquisitions, a global pharma company unified fragmented safety operations with APCER's governance, processes, and operational support.
Case Study
A leading biotech transitioned post-marketing safety operations on an aggressive go live date, while maintaining quality and compliance.
Seeking a unique solution? Speak to our experts
Our Pharmacovigilance Services: Where Safety, Science, and Accountability Converge
Trusted Expertise for Essential Pharmacovigilance Responsibilities
Pharmacovigilance Built on Expertise. Delivered with Precision. Powered by Technology.
How our Technology fits together across the PV Ecosystem.
Oracle ARGUS 25.1 (including Analytics and Insights), LSMV/LSRA from ARIS and ANSA PV SafetyCore, our proprietary next generation AI powered safety database.
ANSA PV SafetyFlow is our proprietary AI-driven intake and case processing tool that improves speed, accuracy, and consistency, with expert oversight.
ANSA PV LitSense is our proprietary end-to-end AI-powered tool for literature screening and review ensuring efficient, consistent, and traceable surveillance outcomes.
Advanced analytics using technology tools, with expert evaluation for robust signal detection and decision-making.
ANSA PV REMSConnect is our customizable, configurable web portal that enables compliant, scalable, and efficient risk management program execution.
Ready for a partner who matches your ambition?
APCER brings scientific rigor, accountability, and a focus on your goals. Let's advance safe, effective therapies together.
Quality and Compliance
- Version-controlled SOPs
- Role-based structured training
- End-to-end Deviation and CAPA lifecycle management
- Risk-based audit program
- electronic Quality Management System (eQMS) and electronic Learning Management System (eLMS)
Ready for a partner who matches your ambition?
With APCER, you gain more than a service provider—you secure a champion for compliance, a catalyst for growth, and a steadfast ally dedicated to protecting patients and your reputation.
Meet Our Experts
Dr. Frank Laschewski
MD (Internal Medicine)
QPPV
Dr. Prachi Arora
MD (Pharmacology)
Vice President and Head, Medical Safety
Binoy Sharma
M.Pharm (Pharmacology)
Vice President - Pharmacovigilance
Amrit Kaur
BHMS, PGDCR, PMP
Vice President - Pharmacovigilance
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
