Classe 35
Regulatory submission managementassisting 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 sitesbusiness consultation and management in the field of clinical trialsspecificallyproviding 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 servicesproviding independent review and oversight of clinical trials involving genetically engineered gene therapy and vaccine research for business purposes
Classe 40
Consulting services in the field of manufacturing compliance and validationproviding technical advice related to the manufacture of pharmaceuticals
Classe 42
Contract research organization (CRO) servicesmonitoring of clinical trials for investigational drugs of biotech and pharmaceutical companiesclinical trial project management and quality assurancemedical writing of investigational drug protocolsmedical research in the nature of biostatistical analysis; consulting services in the field of conducting clinical trialsdrug developmentmanufacturing environmental compliance and validationadvanced technology in the pharmaceutical fieldmedical research in the nature of clinical benchmarking used to improve the performance of professionals in the fields of international healththe pharmaceutical industrythe 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 othersproviding implementation services relating to the development and validation of drugsdevices and biologics; providing institutional biosafety committee servicesreview and oversight of clinical trials involving genetically engineered gene therapy and vaccine researchspecificallyevaluating 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 researchtestinganalysisevaluation of gene therapy and vaccine research service providers to determine conformity with established accreditation standards; consultation services in the nature of quality managementquality evaluation and analysisquality assurancequality control in the field of clinicalmedicalbiological 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 complianceanalysis 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
Classe 45
Legal researchregulatory research in the pharmaceutical industrybiotechnology 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 othersreviewing standards and practices to assure compliance with laws and regulations in the fields of pharmaceuticalveterinarypharmacogenomicbiotechnical and medical products and devices; providing information relating to legal affairsproviding regulatory information relating to the development and validation of drugsdevices and biologics; regulatory compliance consulting as it applies to clinical trialsmonitoring by clinical research administrators for compliance with regulations governing clinical trials; legal document preparation servicespreparation 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 validationregulatory compliance consulting as it applies to prescription drug sampling; consulting services in the field of clinical benchmarking and performance improvementproviding 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 diligencestrategic developmentregulatory 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 servicesindependent review and oversight of clinical trials involving genetically engineered gene therapy and vaccine researchspecificallyreviewing 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 researchreviewing 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 clinicalmedicalbiological 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 complianceregulatory compliance consultation services in the field of clinical trials involving human subjects