Some highlights of our record of results...

• Successfully prepared and obtained approval for twelve New Drug Applications (NDAs) for treatment of hypertension, glaucoma, cardiovascular, pulmonary and infectious diseases, prophylactic vaccines, and agents for diagnostic use.
• Carried out Due Diligence investigation for a venture capitalist interested in acquiring drug product under development by a small pharmaceutical company. Assessed the adequacy of the pre-clinical and clinical study results and the clinical development plan in terms of whether they provided evidence for efficacy and safety required by regulatory agencies.
• For a premier Biotechnology company with a very promising compound in development, evaluated completeness of the company's Drug Development Process (DDP), both in scope and depth, in conjunction with the management and technical environment. Identified significant gaps. Made concrete recommendations for closing identified gaps and laid out methods of implementation.
• For the same company, used preparation of Common Technical Document (CTD) as the primary evaluation tool, investigated how much progress the company had made in filling gaps identified earlier. Scope of the analysis covered the development and implementation of required drug development infrastructure, technology platforms, applications, tools, and processes in Clinical Research, Non-Clinical Research, Pharmaceutical Sciences, Production, and in Project Management departments.
• Directed multinational clinical development project to a successful completion by managing statistical, data management, and programming work of the client company and its numerous European and American Clinical Research Organization (CRO) development partners.
• Led team of international scientists of Fortune 20 information technology company in assessing commercial potential of their new technologies -- including product knowledge bases, data marts, and warehouse technologies -- and consulting services for use in the drug development process.
• Developed and implemented a uniform Biometrics Process that made use of "best industry practices" in a decentralized multinational CRO with five independent Business Centers.
• Evaluated operations and infrastructure of two key departments of a mid-sized pharmaceutical company; realigned the organizational structure, standardized clinical data processing and programming, and defined proper technology and staff skill mix for efficient operation.