Quality Assurance & Regulatory Affairs Specialist
Christopher SmithCQE, RAC
Has successfully submitted and obtained FDA approval for NDAs, ANDAs, INDs, IMPDs, CTDs, MAs, DMFs, amendments and supplements.
- Submissions
- NDA
- ANDA
- DMF
- GCP
- Microbiology
30+ years FDA and industry
Background
Chris Smith is an accredited quality assurance and regulatory affairs professional (CQE and RAC) with more than 30 years of combined FDA and industry experience. His expertise spans a wide area of pharmaceutical compliance, including mock FDA GMP audits of production and laboratory operations and clinical trial GXP and GCP audits.
In industry he worked in regulatory affairs and has successfully submitted and received FDA approval for regulatory documents including NDAs, ANDAs, INDs, IMPDs, CTDs, MAs, DMFs, and amendments and supplements. He works with executive management advising on and writing responses to FD-483s and Warning Letters, and attends FDA meetings with clients.
He has published articles in FDA News, Interpharm Press Inc. and other healthcare publications.
What Christopher does on an engagement
- NDA, ANDA, IND, IMPD, CTD, MA and DMF preparation
- Amendments, supplements and Agency correspondence
- Mock FDA GMP audits — production and laboratory
- Clinical trial GXP and GCP audits
- FD-483 and Warning Letter response drafting
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