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; organizing and administering a network of research sites, namely, business consultation and management in the field of clinical trials, specifically, providing governmental registration assistance in the nature of regulatory submission management on behalf of research sites that conduct gene therapy and vaccine research to assist them with clinical research and clinical trials; providing institutional biosafety committee services, namely, providing independent review and oversight of clinical trials involving genetically engineered gene therapy and vaccine research for business purposes

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; providing institutional biosafety committee services, namely, review and oversight of clinical trials involving genetically engineered gene therapy and vaccine research, specifically, evaluating research sites involved in gene therapy and vaccine research clinical trials to determine whether the organizations conform to an established accreditation standard; assessing the readiness of research sites to conduct gene therapy and vaccine research, namely, testing, analysis, and evaluation of gene therapy and vaccine research service providers to determine conformity with established accreditation standards; consultation services in the nature of quality management, namely, quality evaluation and analysis, quality assurance, and quality control in the field of clinical, medical, and biological research studies; consultation services in the field of drug and medical device development; consultation services in the field of conducting clinical trials for others; consultation services in the field of scientific research compliance, namely, analysis and evaluation of scientific research of others in the field of clinical trials involving human subjects to assure compliance with industry standards; consultation services in the field of scientific research administration and operations in the field of clinical trials involving human subjects; consultation services in the field of product research and development and scientific research and development

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; providing regulatory compliance consultation services in the nature of advice concerning due diligence, strategic development, and regulatory policy in the field of clinical trials involving human subjects; providing information relating to regulatory compliance for independent review of clinical trials involving human subjects; providing institutional biosafety committee services, namely, independent review and oversight of clinical trials involving genetically engineered gene therapy and vaccine research, specifically, reviewing research protocols and related information to ensure protection of the rights and welfare of human subjects of research; assessing the readiness of research sites to conduct gene therapy and vaccine research, namely, reviewing standards and practices to assure compliance with laws and regulations in the field of clinical trials involving human subjects; regulatory compliance consultation services in the nature of health inspection readiness and remediation in the field of clinical, medical, and biological research studies; consultation services in the field of pharmacovigilance strategies to ensure regulatory compliance and patient safety in the field of clinical trials involving human subjects; regulatory compliance consultation services in the field of informed consent protocols for clinical trial participants; consultation services in the field of research compliance, namely, regulatory compliance consultation services in the field of clinical trials involving human subjects