B BEAUFORT

Regulatory submission management, namely, assisting others in preparing Investigational New Drug applications (INDs) and New Drug Applications (NDAs) for submission to the FDA; database management

Consulting services in the field of manufacturing compliance and validation, namely, providing technical advice related to the manufacture of pharmaceuticals

Contract research organization (CRO) services, namely, monitoring of clinical trials for investigational drugs of biotech and pharmaceutical companies, clinical trial project management and quality assurance, medical writing of investigational drug protocols, and medical research in the nature of biostatistical analysis; consulting services in the field of conducting clinical trials, drug development, manufacturing environmental compliance and validation, advanced technology in the pharmaceutical field, and medical research in the nature of clinical benchmarking used to improve the performance of professionals in the fields of international health, the pharmaceutical industry, the biotechnology industry and the medical device and diagnostics industries; providing quality assurance services in the field of regulatory submissions to the FDA by life sciences companies to ensure validity and accuracy; product development for others, namely, providing implementation services relating to the development and validation of drugs, devices and biologics

Legal research, namely, regulatory research in the pharmaceutical industry, biotechnology industry and the medical and diagnostics industry; consultation in the field of regulatory compliance to ensure validity and accuracy of regulatory submissions to the FDA by life sciences companies; conducting regulatory and compliance audits for others, namely, reviewing standards and practices to assure compliance with laws and regulations in the fields of pharmaceutical, veterinary, pharmacogenomic, biotechnical and medical products and devices; providing information relating to legal affairs, namely, providing regulatory information relating to the development and validation of drugs, devices and biologics; regulatory compliance consulting as it applies to clinical trials, namely, monitoring by clinical research administrators for compliance with regulations governing clinical trials; legal document preparation services, namely, preparation of Investigational New Drug applications (INDs) and New Drug Applications (NDAs) for submission to the FDA; consulting services in the field of regulatory affairs and manufacturing compliance and validation, namely, regulatory compliance consulting as it applies to prescription drug sampling; consulting services in the field of clinical benchmarking and performance improvement, namely, providing independent review of clinical trials involving human subjects in the nature of reviewing research protocols and related information to ensure protection of the rights and welfare of human subjects of research