RAPID

Owners

Goods & Services

Design and development of computer software for use in identifying regulatory framework avenues; Design and development of computer software for use in creating and implementing regulatory strategies; Design and development of on-line computer software systems for use in identifying regulatory framework avenues and the creation and implementation of regulatory strategies; Providing a website featuring resources, namely, non-downloadable software for information, advisory, consultancy services with regard to government regulatory strategy generation for medical devices, drug products, biologics, combination products, general wellness products, enforcement discretion products, cellular products, gene products, tissue products, and dietary supplements; Providing an online non-downloadable Internet-based system application featuring technology enabling users to identify regulatory framework avenues; Providing temporary use of on-line non-downloadable cloud computing software for the creation of regulatory strategies; Providing temporary use of on-line non-downloadable software development tools for use in identifying, creating and implementing government regulatory strategies for premarket notifications, premarket approval, humanitarian device exemption, de novo pathway and exempt devices, new drug applications, abbreviated new drug applications, OTC monographs, biologic license applications, and biosimilar biologic license applications applicable for medical devices, drug products, biologics, combination products, general wellness products, enforcement discretion products, cellular products, gene products, tissue products, and dietary supplements; Software as a service (SAAS) services featuring software for determining viability of, recommendations for and development of regulatory strategies; Consulting services for others in the field of design, planning, and implementation project management of regulators strategy frameworks for government premarket notifications, premarket approval, humanitarian device exemption, de novo pathway, exempt devices, new drug applications, abbreviated new drug applications, OTC monographs, biologic license applications, and biosimilar biologic license applications for medical devices, drug products, biologics, combination products, general wellness products, enforcement discretion products, cellular products, gene products, tissue products, and dietary supplements; all of the foregoing excluding services related to radiopharmaceutical therapy, or radiopharmaceuticals pertaining to dosimetry, risk analysis and quantitative reconstruction