45 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
Trademark: 97753728
