Consulting services in the field of pharmaceuticals and biotechnology, namely,: research and development; FDA and non-US drug regulation compliance and enforcement; laboratory testing; diagnostics; operations management; program and project management; quality and risk management; pharmaceutical drug manufacturing and contract manufacturing; technology and site acquisition and transfer; remediation efforts; due diligence and audit; pharmacokinetics and biostatistics; study and trial design and support; and testing, modeling and simulation; new drug approval processing