ACTUALIZED Science

Submissions to the Food and Drug Administration	Organize development materials (research documentation, published articles, data bases, etc.) into FDA submission formats. Perform Gap-Analysis on development documentation and design the sequence of steps required to achieve commercial distribution.
Quality Assurance and Quality Control Documents	Design and perform regulatory monitoring,Data Management, and Final Report on regulated (Good Laboratory Practices and Good Clinical Practices) studies. Write Standard Operating Procedures for GLP, GMP and GCP compliance and provide the instructive training.