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Regulatory Affairs
Regulatory Affairs
Comprehensive Regulatory Support for Global Compliance
Delivering end-to-end regulatory services to ensure successful product development, market approval, and ongoing regulatory compliance across all territories.
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Pharmacovigilance
Pharmacovigilance
Integrated Safety Management from Development to Market
Delivering end-to-end pharmacovigilance services to ensure the highest standards of drug safety and regulatory compliance globally.
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Local Affiliate Services
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Company
Company
Excellence in Pharmacovigilance & Regulatory Affairs
Superior quality pharmacovigilance and regulatory affairs services helping the pharmaceutical industry make safe and effective healthcare products available worldwide.
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Litscreener™

Our cutting-edge, proprietary Local Literature Monitoring System, designed to revolutionize how local literature screening is managed and executed.
Our Local Literature Screening Technology

When you choose us as your local literature screening partner, you benefit from more than just a service – you gain the confidence that your outsourced process is handled with ultimate precision, efficiency, and unwavering commitment to quality.

Behind the scenes, we leverage Litscreener™ - our internally developed technology, built on deep expertise and long-standing experience – to deliver superior process control, quality, and oversight for all our Local Literature Screening processes.

  • Fully Digital & Automated Process
    • • Automated workflows, enabling highly efficient and accurate management of your literature screening needs.
    • • Built-in deadline controls and alerts ensure timely completion and compliance.
    • • Complete audit trails offer transparency and ensure robust internal quality control.
    • • GxP compliant and GAMP 5 validated, meeting the most stringent regulatory standards.
  • Enhanced Oversight & Quality Control
    • • Comprehensive oversight of the entire LLS strategy lifecycle
    • • Full control and oversight of the weekly literature review and reporting process
    • • Continuous monitoring of source issue publication/receipt, review dates, and publishing cycles
    • • Rigorous oversight of QC processes, ensuring timely QC process completion and LLS accuracy
How You Benefit from Our Advanced Processes
CTIS safety reporting changes
  • Quality & Process Control
    • By automating and digitalizing the entire process, we minimize human error, ensuring you receive accurate, timely, and compliant results - every time. Our advanced system & service guarantees that your literature screening is managed with the highest level of precision and oversight, delivering consistent, reliable outcomes.
  • Assurance of Robust Oversight
    • With Litscreener™, every step of the process is meticulously tracked, ensuring that your outsourced responsibilities are handled with the highest level of diligence and precision. From tracking timelines to managing quality checks, our system enhances oversight, providing consistent and reliable execution throughout the entire process.
  • Cost Efficiency
    • The efficiency gains we realize through automation translate into cost savings for you. By reducing the manual labor typically associated with local literature screening, we can offer competitive pricing while maintaining the highest quality standards.
  • Complete Regulatory Compliance
    • Our Litscreener™ ensures full compliance with industry regulations, so you can be confident that every aspect of your local literature monitoring meets regulatory requirements without you having to worry about the details.
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