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We help to align your pharmacovigilance strategy with regulatory expectations and business goals.
What is Pharmacovigilance?
Pharmacovigilance is the science and practice concerned with the detection, collection, evaluation, understanding, and prevention of adverse events (AEs) or any drug-related problems. Essentially, it’s the safety net that ensures medicines do more good than harm throughout their lifecycle. Pharmacovigilance is about protecting patients and promoting public health by closely tracking how medicines perform once they reach the market.
The Need for a Pharmacovigilance Department
In India, compliance isn’t optional. As outlined in Revised Schedule M, Clause 6.11, all licensed drug entities are required to maintain a pharmacovigilance system. This includes the ability to collect, assess, and forward adverse drug reaction (ADR) reports to relevant authorities. These regulations are designed to make pharmaceutical stakeholders accountable and responsive when safety concerns arise.
Who Qualifies as a Licensee?
As per the Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products, the term licensee refers to the Marketing Authorization Holder (MAH). The MAH can be a manufacturer, marketer, or importer of a drug who holds a valid manufacturing, marketing, or import license in India
Pharmacovigilance Solutions: The Core Principles
Pharmacovigilance isn’t a one-time task; it’s a continuous process that supports drug safety after approval. These services, typically provided by Pharmacovigilance consultancies, help identify risks early through the ongoing assessment of adverse reactions. Quick detection allows health authorities to act fast—whether that means revising safety labels or initiating a product recall.
Vaayath Consulting offers a full suite of pharmacovigilance services tailored to today’s complex regulatory environment. Our team brings deep regulatory knowledge, technological expertise, and operational precision to deliver comprehensive PV systems aligned with global standards. From case processing to risk management, our experts help pharmaceutical companies maintain compliance and prioritize patient safety.
Our Pharmacovigilance Services
At Vaayath Consulting Services, we offer integrated pharmacovigilance solutions designed for Indian and global pharmaceutical firms. We help companies stay compliant and patient-focused across all safety-related operations.
Key Service Areas:
- Setup of a fully compliant Pharmacovigilance framework (including SOPs and QPPV resources)
- Adverse event data collection, review, and submission
- Periodic Safety Update Reports (PSUR)
- Individual Case Safety Reports (ICSR) processing
- Proactive signal detection and risk planning
- Adherence to standards like ICH, GVP, US FDA, EMA, and CDSCO
Why Choose Vaayath Consulting?
✔ Extensive experience in Indian and international Pharmacovigilance regulations
✔ Tailored services for MAHs, manufacturers, and importers
✔ Guidance through audits and regulatory inspections
Committed to Safety and Compliance
In today’s health-conscious and tightly regulated market, building a solid pharmacovigilance system isn’t just mandatory—it’s a vital step in protecting lives. With Vaayath Consulting by your side, you gain a partner that ensures both compliance and care.
We Offered Various Services Includes :-
1. Setup of a fully compliant Pharmacovigilance framework
We design and implement robust pharmacovigilance frameworks that meet global regulatory standards. This includes developing tailored Standard Operating Procedures (SOPs), appointing qualified QPPV resources, and integrating compliant workflows across safety systems. Our frameworks are built to ensure inspection readiness, operational consistency, and seamless regulatory alignment.
2. ICSR Processing & Submission
We offer end-to-end management of Individual Case Safety Reports (ICSRs), ensuring accurate and timely reporting of drug-related adverse events. Our experts handle the complete cycle—from data entry to medical evaluation and final submission—leveraging industry-standard platforms to maintain regulatory accuracy.
3. Literature Monitoring
Stay informed with our vigilant literature monitoring services. We scan scientific publications and databases globally to catch safety signals early, identifying reportable events and keeping you aligned with Good Pharmacovigilance Practices (GVP).
4. Risk Management
Our customized Risk Management Plans (RMPs) help identify and mitigate safety risks across a drug’s lifecycle. Through data-driven strategies and thorough assessments, we support effective risk minimization and benefit-risk optimization.
5. Audit and Compliance
We conduct detailed audits, perform gap assessments, and provide compliance roadmaps to help you meet both national and global Pharmacovigilance requirements—minimizing risk and ensuring operational readiness for inspections.
6. Signal Management
From detecting potential safety issues to assessing and documenting them, we offer a full spectrum of signal management services. Our methodical approach ensures timely action and transparent regulatory communication.
7. QPPV Services
Our Qualified Person for Pharmacovigilance (QPPV) professionals oversee your Pharmacovigilance operations with accountability and diligence. They serve as a reliable liaison with EU regulators, ensuring that your system remains compliant and audit-ready.
8. PSUR Submission
We support the creation and submission of Periodic Safety Update Reports (PSURs), ensuring alignment with ICH E2C standards. Our thorough reviews help maintain the right balance between therapeutic benefit and risk.