Expert Directory
Having an expert witness or consultant at your side can help you navigate complex situations with confidence. These professionals understand your industry and excel at conveying crucial information, whether in a courtroom or a consulting environment. At Intellex, we have experts in over 30,000 areas in our database. We enable you to partner with an individual who has the knowledge, educational background, and relevant experience to support your needs effectively.
Utilize our expert finder tool to handpick the ideal mentor or consultant for your specific application.
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…