Elemental Impurities Risk Assessment
Kymanox Risk Assessment for Elemental Impurities in Pharmaceutical Products
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:
- Final Risk Assessment
Base price: $14,990.00
Please contact our team directly at firstname.lastname@example.org to discuss custom options to meet your company’s specific needs in regards to elemental impurities.
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)
|East / Midwest for US / Canada||251||1000||$1500|
|West for US / Canada||1001||2500||$2000|