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Drug Safety / Pharmacovigilance

Comprehensive Pre- and Post-Marketing Drug Safety Services

handshakeIn today’s pharmaceutical, biopharmaceutical and medical device product landscape, you can’t afford to miss crucial safety information about your products. From preclinical studies to post-marketing settings, BioPoint has the broad-based experience to provide comprehensive clinical and post-marketed drug safety and pharmacovigilance consulting services to help you address product safety concerns in a confident, proactive manner.

A pharmacovigilance and drug safety expert from BioPoint acts as a direct extension of your team to assist with:

  • Clinical and Marketed Individual Case Safety Reports – Prepares regulatory-ready serious and non-serious safety reports for clinical and marketed products, ensuring full compliance with client-approved operating procedures from initial event capture to submission-ready regulatory forms.
  • Aggregate Safety Reports – Development of all clinical and marketed periodic reports for planned regulatory response, including country-specific reports.
  • Scientific Literature Surveillance – Provide outsourced options to support existing client safety organizations.
  • Safety Signal Detection – BioPoint can conduct all or part of your clinical and marketed signal detection and analysis.
  • Epidemiology Consultation – Oversees the development of study design, data collection, and analysis plans, and prepares final reports summarizing study results.
  • Risk Management – We assist clients daily with the development of clinical and post-approval strategies. BioPoint also provides pharmacovigilance consulting and planning services, including the development of key clinical and marketed safety specifications and risk minimization plans.
  • Regulatory Consultation – BioPoint provides effective regulatory assessment and strategy for product development, including regulatory filings and other consultative services (e.g., post-approval commitments, new drug application strategies and regulatory agency advisory committee meetings).

 

Do You Need Drug Safety Expertise?

Contact us today

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