Drug Safety

Advancing Patient Safety with
data driven decisions

Fidelity Health Services Pvt. Ltd. offers comprehensive drug safety services to protect patient well-being throughout a medication's lifecycle. Our expert team excels in clinical safety and pharmacovigilance, utilizing trending technology for efficient Individual Case Safety Report (ICSR) Processing. With a deep understanding of regulations, we provide thorough analysis and generate valuable insights that enhance quality of life.

Our suite of solutions includes advanced pharmacovigilance tools and streamlined processes to ensure timely identification and mitigation of potential risks. By combining expertise with updated systems, we're committed to advancing patient safety through data-driven decisions, ultimately supporting pharmaceutical companies in delivering safer, more effective treatments to patients worldwide.

ICSRs Processing and Submission

We provide a cost-effective solution for managing safety data and taking care of your future requirements for processing ICSRs and enabling global reporting on time

Literature Management

As a team of literature reviewers, we craft meticulous search strategies to identify adverse events that impact case processing, aggregate relevant reports, and manage emerging signals. By thoroughly screening available data, we can effectively monitor and analyze trends, ultimately supporting improved patient safety and outcomes. Our systematic approach ensures comprehensive coverage and timely detection of potential issues, enabling us to provide valuable insights to stakeholders.

Aggregate Report Management

We support you throughout the drug safety services’ life cycle, including development and post-marketing phases. Our team creates and submits accurate, first-time-right reports for all stages, including routine and ad-hoc aggregate reports. We manage every aspect of report creation and submission, ensuring timely and reliable data for stakeholders. This enables informed decision-making and efficient regulatory compliance.

  • DSURDevelopment Safety Update Report
  • PADERPeriodic Adverse Drug Experience
  • PBRERReport Periodic Benefit Risk Evaluation
  • PSURReport Periodic Safety Update Report
  • ASRAnnual Safety Report
  • ACOAddendum to Clinical Outcomes

Signal Management

We pore through every element of adverse event data to identify patterns and propose new safety information and activities triggered by the discovery of a new signal.


Signal Validation
and Confirmation

Signal Analysis
and Prioritization


for action

Risk Management Plan

We take a rational, proactive approach to identified and potential risks. FHS team of specialists designs targeted, accurate risk minimization measures. We compile, compose, and update comprehensive Risk Management Plans (RMPs) for global regulatory bodies. Our prime objective is to identify potential problems early and address any issues before they escalate. This enables us to effectively mitigate risks and ensure the safe use of pharmaceutical products throughout their lifecycle.

Safety information reviews & revisions
All sections of
medical assessments
Full safety
Efficient risk minimization measures

What makes us preferred
Drug Safety partner

Navigating the dynamic pharmacovigilance facilities we provide the confidence you need in your drug safety solution.
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