Medical Information

Adverse event and product technical complaint reporting

Management of events from recognition to submission

Supporting and reassuring you with a complete range of high-quality services.

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Colin Watson

t+44 1530 562300

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Regulatory requirements mean there is more importance for timely and accurate submission of adverse event (AE) reports and product technical complaints (PTC)

Recording and monitoring of AE and PTC for medicines and devices, with full management of reported complaint, sample return, investigation and complainant reporting.

Our Adverse Event Reports and Product Technical Complaint services include:

  • Domestic and global cases
  • Medical products / device products or investigational drugs / device products
  • AE intake case entry into database
  • Case quality review
  • PTC intake case entry into database
  • Facilitation of pharmacy exchanges
  • Facilitation of product retrieval for investigational purposes
  • Reconciliation of all reports and cases

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