Pharmacovigilance Consultancy Services

Regulatory Guidance

We provide clear and actionable regulatory advice on stipulations, requisites, advertising protocols, and validating medical claims, ensuring your product and practices align with evolving standards.

Pharmacovigilance System Management

We assist in both establishing and managing the pharmacovigilance system, assuring an agile and responsive safety monitoring environment.

Pharmacovigilance System Master File (PSMF)

Trust our experts for meticulous preparation and ongoing maintenance of the PSMF, providing you with an always up-to-date and regulatory-compliant record.

Document Review and Oversight

We offer thorough review services for critical safety and efficacy documents, including but not limited to Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Drug Safety Update Report (DSUR), Risk Management Plan (RMP), and Signal Evaluation Reports. Furthermore, our team gives a detailed overview of the safety profile, addressing all safety concerns related to medical products.

Adverse Reaction Management

We oversee and facilitate precise reporting of Adverse Drug Reactions (ADR), product quality complaints, and crucial medical information pertinent to pharmaceuticals and medical devices.

Regulatory Notifications

As part of our pharmacovigilance consulting services, our Qualified Person Responsible for Pharmacovigilance (QPPV) ensures timely and accurate notifications to pertinent regulatory bodies.

Continuous Safety Monitoring

We engage in ongoing monitoring of the safety profile of medicinal products, covering all facets from signal detection, risk-benefit ratio assessment, to duly notifying regulatory authorities about a product's safety profile.

Post Authorization Safety Study (PASS)

Leverage our expertise to conduct rigorous post-authorization safety studies, reinforcing product safety and minimizing risks.