Thomas Walker

Background

About Thomas Walker

More than twenty-five years of analytical chemistry, QC, QA and regulatory experience in pharmaceuticals. • Redesigned the quality systems and quality control department of an API manufacturer in South Korea, China and USA. Helped South Korean manufacturer to be removed from FDA and EMA import bans. • Provided guidance and support for analytical method development and validation at ce2l for pharmaceutical clients. • Development, start up and qualification of QC laboratories, QA Department and Document Control functions for API suppliers. • Involved in the development, start up and qualification of cGMP analytical, QC and GLP bioanalytical laboratories. • Experience in the development and regulatory filings of INDs, ANDAs, NDAs, eCTDs. • Expertise in separation science HPLC, UPLC, IC. • cGMP audits of analytical and QC laboratories, bioanalytical laboratories, drug substance and drug product sites in the USA, Europe, South Korea, China and Japan. • Quality Assurance function for a cGMP/GLP analytical/bioanalytical laboratory. • Involved in the writing, preparation and review of eCTD, INDs, ANDAs and NDAs. • Interacted with the National Cancer Institute, FDA and USP on current and pending pharmaceutical products. Specialties: Analytical chemistry, HPLC, ion chromatography, chiral chromatography, UHPLC, technical writing, GMP and GLP auditing, expert witness, bioanalytical chemistry, on-site and hands-on analytical chemistry consulting, method development, method validation, technical transfer, setup of analytical, bioanalytical and QC laboratories. Preparation and writing of scientific documents and reports. Preparation and writing of CMC section for NDAs, ANDAs and INDs. Experience with oligonucleotide APIs.