• Pharmacovigilance Services

  • Adverse Event (AE) Reporting: Collecting, reviewing, and reporting AEs to regulatory authorities and sponsors.
  • Signal Detection: Identifying potential safety signals from AE data and literature reviews.
  • Risk Management: Developing and implementing risk management plans (RMPs) to mitigate safety risks.
  • Regulatory Compliance: Ensuring compliance with Local pharmacovigilance regulations and guidelines.
  • Literature Review: Conducting literature searches to identify potential safety issues.
  • Safety Data Exchange (SDX): Managing and exchanging safety data with partners and regulatory authorities.
  • Pharmacovigilance System Audits: Conducting internal and external audits to assess the quality and compliance of pharmacovigilance systems.
  • Training and Education: Providing training and education on pharmacovigilance topics to employees and other stakeholders.
  • Data Management: Managing and analyzing pharmacovigilance data.
  • Medical Writing: Drafting safety reports, RMPs, and other safety documents.
  • Implementation of PV Systems for new products or companies.
  • Outsourcing Services: Providing outsourced pharmacovigilance services to pharmaceutical companies.
  • Medical Information Services: Providing medical information to healthcare professionals and patients.