Pharmacovigilance · Regulatory Affairs

Excellence in Pharmacovigilance, Drug Safety & Regulatory Compliance

A trusted partner providing specialised Pharmacovigilance and Regulatory support throughout the product lifecycle.

Understand. Execute. Review. Improve.

We combine scientific expertise, regulatory understanding, defined processes and appropriate technology to deliver work that is clear, controlled and traceable.

Technology-Enabled. Scientifically Controlled. Regulatory-Conscious.

We combine modern technology, intelligent workflows, and specialist Pharmacovigilance expertise to deliver operations that are connected, traceable, scalable, and built for regulatory expectations.

Proactive Drug Safety. Every Signal, Reviewed.

End-to-end case intake, assessment, and safety reporting delivered with scientific rigour and complete regulatory traceability.

Our Mission

To be a globally trusted leader in Pharmacovigilance, advancing drug safety, regulatory compliance, and patient protection through scientific excellence and innovative safety solutions.

Who We Are

VIGIVANCE was founded by a team of medical experts, pharmacologists and pharmaceutical professionals, bringing together multidisciplinary expertise across Pharmacovigilance, Regulatory Affairs, Medical Writing and Clinical support.

Strategically located in Central India, serving pharmaceutical organisations across global markets.

About VIGIVANCE →

What We Do

We provide integrated solutions across the pharmaceutical product lifecycle. Our expertise spans Clinical Support, Regulatory Affairs, Pharmacovigilance, and Patient Safety, helping organizations achieve compliance and manage products with confidence.

Pharmacovigilance

End-to-end pharmacovigilance support aligned with applicable regulatory requirements and GVP principles.

ICSR ManagementSafety SurveillanceSignal ManagementPSUR/PBRERQPPV Support

Regulatory Affairs

Regulatory and compliance support across product registration, lifecycle management, and post-marketing obligations.

Regulatory StrategyDossier SupportRegistrations & RenewalsLabelling & Artwork Management

Clinical Support

Operational and scientific support for clinical studies in accordance with applicable regulatory and quality requirements.

Site IdentificationSite FeasibilityStudy CoordinationMonitoring Support

Medical Writing

Scientifically rigorous medical and regulatory documentation supporting development, safety evaluation, and regulatory submissions.

Clinical ReportsSafety WritingScientific LiteratureRegulatory Documentation

Support Across the Product Lifecycle

DevelopmentClinicalRegulatoryLaunchPost-Marketing
Our Approach

Understand. Execute. Review. Improve.

We combine scientific expertise, regulatory understanding, defined processes and appropriate technology to deliver work that is clear, controlled and traceable.

Tailored by scope. Structured for compliance. Designed for continuity.

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Flexible Engagement Models

Whether establishing a new capability, enhancing an existing system, or transferring defined activities, our engagement model is structured around your operational and regulatory requirements.

Transform

Assess, remediate, and enhance existing processes, systems, and compliance frameworks.

Extend

Provide targeted specialist expertise and additional capacity where required.

Outsource

Assume defined activities or functions through a structured, quality-controlled external service model.

Let's Start With Your Requirement.

Whether you are building, strengthening, extending, or outsourcing your Pharmacovigilance function, or require Regulatory, Medical Writing, or Clinical support, we align the scope, expertise, technology, and delivery model to your requirements.

Tell us what you need. We'll define the right approach.