Key Personnel: President: David McCarthy, Executive Associate: Tessa Hogerwaard, Mktg Mgr: Matt McCarthy

Description: Services include preparation of drug submissions, (NDS, S/NDS, IND, DIN), plant and product master files, GMP/ISO audits against FDA and HPB requirements, regulatory strategic planning, writing and assessing SOPs, regulatory and GMP training programs, assessing and preparing validation protocols and pharmacoeconomic evaluations.