Pharmacovigilance

Welcome to SEMELO Health Care Company, where excellence in Pharmacovigilance meets a steadfast dedication to safety throughout the entire life cycle of your program.

Comprehensive Pharmacovigilance Solutions

 

Our Pharmacovigilance services are meticulously designed to ensure precise global safety reporting in clinical trials, adherence to timelines, and robust support and education for site staff on safety protocols. At SEMELO Health Care Company, our experienced and highly trained safety team includes physicians, registered nurses, clinical pharmacists, and medical technologists, each specializing in the collection, evaluation, and submission of safety data in clinical trials. With a focus on the concise and rapid exchange of safety information among all stakeholders, our team ensures that your safety profile is comprehensively managed and analyzed.

Tailored Expertise and Flexible Solutions

 

Partner with our dedicated Pharmacovigilance team to leverage regulatory knowledge and medical expertise tailored to your specific needs. We offer flexible solutions that can function as an extension of your safety department or as your external Pharmacovigilance team, providing support at the study, program, or company level.

Our Services

 

Our comprehensive range of Pharmacovigilance services includes:

  • Evaluation of Existing Settings: Including literature research, reporting, Periodic Safety Update Reports (PSURs), and alarm plans.
  • Implementation of Pharmacovigilance Systems: Setting up robust systems for effective safety data management.
  • Compilation of Risk Management Plans (RMPs): Developing detailed plans to identify, evaluate, and mitigate risks.
  • Tailor-Made Solutions: Providing customized training and conducting internal audits to fit your organization’s specific needs.

At SEMELO Health Care Company, we are committed to ensuring the safety and well-being of patients throughout the drug development process. Trust us to be your reliable partner in Pharmacovigilance, offering efficient workflows, regulatory compliance, and dedicated support every step of the way.

SEMELO Health Care Company – where expertise meets excellence in Pharmacovigilance.