BioPharm Global, incorporated in November 2000, is a pharmaceutical consulting/contracting firm specializing in pharmaceutical development: the founder of the company, Angus McLean, Ph.D has 20 years experience developing products in the US pharmaceutical industry. Dr. McLean has worked with major pharmaceutical companies such as Schering Plough and also has experience in the "start-up" company environment: he has published extensively in a host of prestigious journals such as The Journal of Clinical Pharmacology, Biopharmaceutics and Drug Disposition, Biochemical Pharmacology, Pharmaceutical Research, Journal of Medicinal Chemistry and Journal of Chromatography.The focus of his experience is the design of optimal regulatory strategy for the drug development program at the Pre-IND stage followed by participation in the implementation of such strategies with a view to timely submissions and approvals by the regulatory authorities. Specialties: Clinical pharmacology-research; Medical-Regulatory Affairs with hands on expertise in the preparation of submission documents e.g. IND'S, CTD sections, CSR'S; Sound statistical and presentation skills applied to the development of efficacy and safety information for regulatory submissions.