GLAERS | Pharmacovigilance Software

Validation Ready Enterprise-Grade PV Software

Automate Global PV Compliance with our integrated consulting and software solutions

Accelerate compliance, slash validation timelines, and reduce total cost of ownership (TCO) with an end-to-end drug safety partner. Glaers delivers top-tier pharmacovigilance consulting and software solutions engineered for modern manufacturers and MAH holders of pharmaceuticals, medical devices, biotech, and CROs looking for an affordable alternative to legacy platforms

ABOUT GLAERS

What We Do

With evolving, dynamic global pharmacovigilance regulatory rules and guidelines, the PV requirements including ADR reporting, evaluation, and submissions are now mandatory and shifted to manufacturers and MAH holders. This increases the cost burden and expenses for companies.

Glaers, a division of Aizilus Technologies, provides affordable end-to-end GxP compliance and pharmacovigilance consulting services, along with our Proprietary Custom-Built, Cloud-Native Software for Regulatory Reporting and Submissions.

Glaers redefines safety operations. We do not just hand over a database; we design, validate, and support your complete safety ecosystem. Our service offering integrates seasoned PV consultants with an ultra-secure cloud-native technology stack, delivering perpetual inspection readiness through a risk-based GAMP 5 approach.

PV Consulting

Global PV Consulting and Compliance Solution including Intake Services, AE Case Processing, Product Complaint Management, PSURs, Audit & Inspection Support

PV Software

Proprietary Cloud Native Software, with US FDA 21 CFR and GAMP 5 compliance, features native XML export, compliant with global ICH E2B(R3) transmission

Custom Solution

Customized solution across lifescience domains including software and app development, Agentic AI, regulatory compliance or business growth solutions

Consulting, AI and Digital Transformation

Why Global Pharma & Biotech Companies Choose GLAERS

With 10+ years of industry expertise, dedicated PV & Regulatory teams and integrated software technology solutions, we are a trusted partner for global pharmacovigilance and compliance needs. Our services and solutions are designed for Pharmaceuticals, Medical Devices and IoT, Biologics, Biosimilars, Generics, Veterinary Products, Traditional Medicines and OTC products. We also support lifestyle and consumer products such as Cosmetics, Health Supplements and Food products, to comply with Regulatory Requirements.

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FDA, EMA & CDSCO Expertise

Comprehensive pharmacovigilance and regulatory affairs support aligned with global requirements and best practices.

End-to-End Drug Safety Services

From adverse event intake to aggregate reporting and signal detection, we manage complete pharmacovigilance operations.

Scalable PV Outsourcing

Flexible outsourcing solutions tailored for startups, mid-size pharma companies, CROs, and global healthcare organizations

Dedicated Experts

Experienced physicians, pharmacists, and life science professionals focused on quality, compliance, and patient safety.

About GLAERS

GLAERS, abbreviated for Global Food and Drug Pharmacovigilance Regulatory Solutions and Software, is a specialty division of Aizilus Technologies, offering full scale consulting and technology solutions for global pharmacovigilance regulatory compliance for manufacturers and MAH holders, in accordance with GAMP 5, US FDA 21 CFR, EU and CDSCO Regulatory Requirements.

GLAERS PV Software is a Proprietary Custom-Built, Cloud-Native, Software for Pharmacovigilance Regulatory Reporting and Submissions, developed by Aizilus Technologies.

Classified as a GAMP Category 4 configured software solution, GLAERS PV Software platform implements a risk-based lifecycle approach aligned directly with the GAMP 5 validation paradigm. This ensures your system is rapidly deployed and certified "fit for intended use" without duplicating supplier testing. By utilizing out-of-the-box, comprehensive risk-based IQ/OQ/PQ protocols, Glaers drastically reduces the computer system validation (CSV) timeline for manufacturers, biotech firms, and contract research organizations (CROs).

At the center of our high-performance architecture is an ultra-secure, FDA 21 CFR Part 11 compliant database that guarantees complete adherence to ALCOA+ data integrity standards.

The platform features automated audit trails and electronic signatures that bind user identity to timestamps, protecting critical data paths against unauthorized alterations.

News & Insights

Stay updated with the latest pharmacovigilance and regulatory compliance trends.

Navigating the Transition to FDA ICH E2B(R3) for Postmarketing ICSR Submissions

New pharmacovigilance guidelines emphasize faster adverse event reporting and improved compliance tracking across India. The revised framework focuses on enhanced patient safety monitoring, streamlined electronic submissions, improved data quality standards, and faster regulatory communication between stakeholders and health authorities.

AI Transforming Pharmacovigilance Operations

Artificial Intelligence is revolutionizing pharmacovigilance by automating case intake, adverse event detection, data processing, and regulatory reporting. Organizations are increasingly adopting AI-driven solutions to improve operational efficiency, reduce manual workload, and strengthen patient safety monitoring across global markets.

Global Regulatory Compliance Trends in 2026

Regulatory agencies including FDA, EMA, and ICH continue to introduce new digital compliance initiatives and reporting standards. Companies must adapt to evolving pharmacovigilance requirements, strengthen data governance practices, and maintain audit-ready systems to ensure seamless regulatory submissions.