Regulatory Bioanalysis

With 10 years of having developed and validated LC-MS/MS and LBA assays, >20 years of regulatory bioanalysis experience up to the Director levels including 9 years of auditing experience in the US, EU, UK and China, Bioaccurate will provide the most comprehensive regulatory bioanalysis support, whether that is auditing, program management, gap analysis or training.   

Because Dr. Chris Tudan has a unique combination of technical and regulatory expertise, audits, gap analysis and lab qualifications would be conducted with the same rigor as a regulatory inspection where even the raw and source data is reviewed and studies and procedures/processes are assessed according to the relevant and current Guidance’s, including the CLSI’s for CLIA LDT’s.

Chris has also taught regulatory bioanalysis at the SQA college (Society of Quality Assurance), and employees of more than 20 corporations in the US and EU, including QA, management and scientific personnel.