We Specialize in the 'Euticals'
The production, marketing and sale of nutraceuticals implicates a complex web of regulation from various levels of state and federal government. As a RNCP in the nutraceutical field, Shelley seamlessly guides each client through guidelines and regulation to enhance each client’s bottom line.
The Food and Drug Administration actively pursues the manufacturers of nutraceuticals that it deems unsafe, while the Federal Trade Commission is extremely aggressive when confronting all parties in the supply chain – including marketers, for misleading or incomplete advertising. Sivana Group brings years of experience to each client engagement with respect to aspects of advertising, labeling and scientific substantiation for nutraceuticals. We stay on top of these constantly changing parameters to ensure compliance and protect each client’s supply chain.
Bringing together regulatory and market access consulting expertise means that we can help our clients address the requirements of regulators, providers, payers and patients holistically. This accelerates timelines, reduces risk of delays, and improves efficiency.
Our firm helps companies to establish a systematic integration of regulatory requirements, patient engagement, and pricing and market access into the R&D process for better, faster drug development. Because ‘the old way’ just isn’t financially sustainable or effective today.
Carefully developed medical devices start here. Now more than ever, developing medical devices takes a keen eye for quality. To help you navigate the regulatory and development landscape while sticking to budgets and timelines, we start with the big picture in mind.
No matter your therapeutic area, we can provide regulatory strategies, manage pre-submission meetings with regulatory bodies, assist with investigational device exemptions, 510(k) applications, and more.
Our compliance experts can help at all stages of development to help you create and maintain a smart quality system, including design controls to meet FDA, EU, and ISO 13485 requirements, among other qualifications.
PSYCHEDELIC & PLANT MEDICINES
Sivana Group provides tailored consulting services to life science companies developing psychedelic therapeutics. Psychedelic business strategy is a complex, emerging field with numerous nuanced requirements. We look to assist values-based companies in navigating these uncharted waters, to ensure affordable and inclusive therapeutics for neurological, immune, and spiritual ailments.