Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety

An essential component of patient safety is pharmacovigilance, which encompasses the science and activities involved in detecting, assessing, understanding, and preventing adverse effects or any other medicine-related issues. As a comprehensive pharmacovigilance service provider, DDReg plays a crucial role in the drug safety landscape and is fully committed to ensuring the highest level of patient safety. Our pharmacovigilance services meet the stringent requirements of regulatory authorities such as the EMA, UK MHRA, and US FDA, and are based on Good Pharmacovigilance Practices (GVP) guidelines.

ICSR Processing

Individual Case Safety Reports (ICSRs) are vital for monitoring the safety profile of medications. Our team at DDReg expertly manages all stages of case reporting, including receipt, duplicate check, triage, data entry, quality check, medical review, and final submission to competent authorities within the required timeframe. We utilize an ICH E2B(R3) compliant database integrated with dictionaries such as MedDRA and the WHO Drug Dictionary to ensure standardization and efficiency in reporting.

Literature Monitoring

Published medical and scientific literature are key sources of adverse event data. Our literature monitoring services involve systematically reviewing scientific articles and reports to identify and assess potential safety concerns, thereby contributing to a comprehensive understanding of a drug's safety profile.​

Risk Management

Effective risk management is essential to minimize potential harm to patients. We develop and implement Risk Management Plans (RMPs) that outline strategies to identify, assess, and mitigate risks associated with pharmaceutical products. These plans are tailored to meet regulatory requirements and are regularly updated to reflect new safety information.

Aggregate Reports

Periodic safety update reports (PSURs) and other aggregate reports are essential for summarizing and analyzing safety data over time. We assist in the preparation and submission of these reports, ensuring they meet regulatory standards and provide a clear overview of the benefit-risk profile of medicinal products.

Signal Management

Signal detection and management are critical for identifying new or changing risks associated with medicines. Our signal management services involve the continuous monitoring and analysis of safety data to detect potential signals, followed by thorough evaluation and appropriate action to ensure patient safety.

QPPV Services

As part of our commitment to pharmacovigilance, we offer Qualified Person Responsible for Pharmacovigilance (QPPV) services. Our experienced QPPVs oversee the pharmacovigilance system, ensuring compliance with regulatory requirements and the effective management of safety data.

Audit & Compliance

Pharmacovigilance audits are essential in confirming that an organization's pharmacovigilance activities comply with the rigorous regulations designed to ensure patient safety.

Compliance with Global Regulations

Our pharmacovigilance services are aligned with the requirements of stringent regulatory authorities such as the European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. Food and Drug Administration (FDA). We adhere to Good Pharmacovigilance Practices (GVP) guidelines, ensuring that our services meet international standards and contribute to the global effort in safeguarding patient health.

The path forward lies in leveraging advanced technologies, fortifying national PV systems, and fostering robust international collaboration. With a strategic and unified approach, the vision of a globally harmonized PV system can become a tangible reality.

At DDReg, we provide pharmacovigilance services through a multifaceted approach that ensures the safety and efficacy of pharmaceutical products throughout their lifecycle. For professional advice and assistance in pharmacovigilance-related queries, get in touch with us at

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