Elemental Impurities Risk Assessment


Kymanox Risk Assessment for Elemental Impurities in Pharmaceutical Products

Product Description

The Kymanox team of technical experts provides turnkey services for analyzing and drafting a FDA/EMA-ready risk assessment for elemental impurities, including required analyses of the manufacturing process and as specified by USP <232>.

Overview of Risk Assessment

  • 2-hr Working meeting with Kymanox SME(s) to review one (1) product and the manufacturing process.
  • Review applicable documentation.
  • Draft risk assessment for elemental impurities

Kymanox deliverables will include:

  1. Final Risk Assessment
  2. SummaryReport

Base price: $14,990.00

Please contact our team directly at info@kymanox.com to discuss custom options to meet your company’s specific needs in regards to elemental impurities.

SKU: SER-10 Category:

Travel Expenses will be calculated during the checkout process based on the table below (Min and Max Distances for Regions are calculated with a starting point of our global headquarters in RTP, NC USA)

Region Min Distance
(in Miles)
Max Distance
(in Miles)
Local 1 100 $0
Extended Local 101 250 $1000
East / Midwest for US / Canada 251 1000 $1500
West for US / Canada 1001 2500 $2000
Extended Distance 2501 - $2500