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Safety First – Driving Pharmacovigilance Services

Pharmacovigilance Services

Pharmacovigilance Services

Safety First – Driving Pharmacovigilance Services

Pharmacovigilance and drug safety play vital roles in the life sciences industry. These functions ensure the safety and efficacy of drug formulations and medical interventions. Pharmacovigilance encompasses two major aspects: determining the effectiveness of a drug and understanding its safety profile.

Partnering with companies experienced in global regulatory requirements ensures inspection readiness and safe usage of therapeutic product.

With an extensive range of offerings, ICBio guarantees end-to-end solutions for your pharmacovigilance needs.

Individual Case Safety Report (ICSR) Services

ICBIO provides a fully managed and well-maintained pharmacovigilance safety database services (hosting, servers, implementation, upgradation, maintenance, and support with CLINEVO

Aggregate Reports Services

For all the reports above, we help determine strategy, review, and analyze data/literature/signals, provide guidance, review, and implement comments.

Signal And Risk Management Services

At ICBio we understand that Signal management is crucial in pharmacovigilance for drug safety and patient health protection. The primary goal is to detect new risks or changes in the safety profile of drugs.

Literature Screening and Review

ICBio offers a comprehensive Global and Local Literature Monitoring service, which is vital in any pharmacovigilance system. Literature provides invaluable early insights into safety issues and facilitates the generation of safety and aggregate reports.

Risk management Plan (RMP) development.

With ICBio, you can trust that your risk management needs are in capable hands. We understand they differ in elements such as the implementation of risk management pharmacovigilance plans and the reporting-time requirements.

QPPV Support

Our QPPV office ensures the smooth functioning of pharmacovigilance systems. They directly oversee implementation and maintenance of a strong pharmacovigilance system for sponsors.

Pharmacovigilance System Master File (PSMF)

We are here to support you in navigating the complexities of PSMF requirements, ensuring your global compliance with pharmacovigilance regulations.

PV Consulting and Additional Support

EudraVigilance Support, Regulatory Intelligence, Pharmacovigilence Audits and Training, SOP writing and Training Services.

Pharmacovigilance Brochures

Let us be your reliable safety companion in your PV journey

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