Scientific document preparation, analysis or assessment.
Preparation and review of IND, NDA and other regulatory documents.
FDA correspondence on matters other than standard submission documents.
Clinical study report preparation and submission.
Package insert preparation.
Dissolution and correlation analyses.
Dosage-form design and formulation development data.
Keywords: Biopharmaceutics, biomedical engineering, pharmacodynamics, clinical trial, pharmacokinetics, pharmacology, pharmacogenetics, dosing regimen, toxicity, drug interaction, ADR, ADE, drug formulation, animal scale-up, population study, medical device, biotechnology, FDA, NDA, IND, ANDA, drug metabolism, drug absorption, drug distribution, drug elimination, drug excretion, pro-drug, drug delivery, mathematical modeling and prediction.