Sandi Schaible

Executive Director, Analytical Chemistry and Regulatory Toxicology

Expertise Areas:

Biocompatibility, Biological Safety, Chemical Characterization, FDA, Preclinical, Regulatory

Related Services:

Sandi Schaible joined NAMSA in March 2025 after the acquisition of WuXi AppTec’s U.S. Medical Device Testing operations. She had been with WuXi AppTec since 2011 and now oversees NAMSA’s Analytical Chemistry and Regulatory Toxicology department in St. Paul, Minnesota.

With over 30 years of experience, Ms. Schaible leads a team providing custom chemistry testing services, including extractables/leachables, materials characterization, and toxicological risk assessments. She has worked in the pharmaceutical, medical device, environmental, and R&D industries, including over 20 years of analytical experience in GLP, GMP, FDA, and ISO-regulated laboratories.

Ms. Schaible is actively involved in standards development and serves as an international and U.S. delegate for TC 194/WG14, the technical committee for ISO 10993-18.

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