LABRYTE

Downloadable computer software for use in laboratory information management, quality assurance, document control, electronic quality management (eQMS), and regulatory compliance in the fields of clinical diagnostics, biotechnology, regenerative medicine, and pharmaceutical development; Downloadable computer software for managing laboratory workflows, coordinating clinical studies, integrating regulatory documentation, and supporting GMP compliance

Business consulting services in the field of clinical diagnostics, biotechnology, regenerative medicine, and pharmaceutical development; Business management consulting and advisory services for the diagnostic laboratories, GMP facilities, and companies developing assays, instruments, stem cell products, exosome-based products, tissue-derived biologics, and drug delivery platforms industry; Business project management services; Business management consulting and advisory services for the laboratory and manufacturing facility build-outs, including planning, contractor coordination, and vendor engagement industry; Business consulting services; Business consulting services in the field of staffing, recruiting, marketing, commercialization strategy, mock audits, laboratory workflow reviews, and B2B networking for laboratory, biotechnology, pharmaceutical, and life sciences companies

Educational services, namely, conducting workshops, webinars, training programs, and continuing education courses in the field of molecular diagnostics, laboratory compliance, biotechnology, regenerative medicine, and pharmaceutical development and distribution of educational materials in connection therewith; Education services, namely, providing workshops, webinars, training programs, and continuing education courses in the field of molecular diagnostics, laboratory compliance, biotechnology, regenerative medicine, and pharmaceutical development; Providing online non-downloadable electronic publications in the nature of training manuals, validation guides, and compliance workbooks in the field of laboratory and biotechnology consulting; Providing educational mentoring services and programs in the field of science, technology, engineering, and mathematics (STEM), with a focus on laboratory sciences, method validations, and regulatory compliance; Training services in the field of science, technology, engineering, and mathematics (STEM), with a focus on laboratory sciences, method validations, and regulatory compliance

Scientific research consulting in the field of molecular diagnostics, biotechnology, regenerative medicine, and life sciences companies; Technological consultation in the technology field of molecular diagnostics, biotechnology, regenerative medicine, and pharmaceuticals; Consulting services for others in the field of design, planning, and implementation project management of setup, validation, and compliance of CLIA-certified laboratories, GMP facilities, and FDA-regulated manufacturing sites; Scientific research consulting in the field of assay, biologic, and drug product development, including molecular diagnostics, stem cells, exosomes, amniotic allografts, and exosome-based drug delivery platforms; Scientific research consulting in the field of method validations, laboratory information systems, document control, quality management systems, and regulatory documentation; Technological consultation in the technology field of biotechnology, pharmaceutical, and regernative medicine companies regarding product design, validation, compliance, and FDA submissions; Software as a service (SAAS) services featuring software for laboratory information management, document control, quality assurance, electronic quality management (eQMS), and regulatory compliance for clinical diagnostics, biotechnology, regenerative medicine, and pharmaceutical development facilities; Platform as a service (PAAS) featuring computer software platforms for managing laboratory workflows, clinical studies, manufacturing processes, and regulatory documentation using cloud-based software; Providing temporary use of on-line non-downloadable software for operations management, data integration, and compliance in the fields of diagnostics, biotechnology, regenerative medicine, and pharmaceuticals

Regulatory compliance consulting in the field of clinical laboratories, biotechnology companies, regenerative medicine organizations, and pharmaceutical developers in connection with CLIA, CAP, GMP, and FDA standards; Regulatory compliance consulting in the field of project management relating to diagnostic assays, medical devices, biologics, stem cells, exosomes, tissue-derived products, drug delivery platforms, and mock audits or pre-inspection readiness reviews; Regulatory compliance consulting in the field of laboratory, biotechnology, and pharmaceutical companies, namely, reviewing standards and practices to assure compliance with governmental regulations and industry standards