Expert Regulatory, Litigation Support, Reimbursement & Pricing Advising for Innovative Healthcare Products and Services
Expert Regulatory, Litigation Support, Reimbursement & Pricing Advising for Innovative Healthcare Products and Services
Today’s global regulatory affairs, reimbursement and pricing environments are evolving rapidly to keep pace with increasingly complex medical device & drug development technology. Development of innovative healthcare products is, in and of itself, not enough to successfully commercialize clinical products in any geographic area. tJûn17 Life Sciences Advisors, LLC works with medical device, ivd diagnostics, biotechnology and specialty pharmaceutical organizations to facilitate the commercialization of innovative and cost effective healthcare technologies. We leverage our substantial expertise to support manufacturers, investment firms, and other stakeholders to develop and execute optimal, comprehensive and strategically aligned regulatory, reimbursement, and pricing and overall marketing strategies. In addition, tJûn17 Life Sciences Advisors effectively supports preparation of compliant regulatory documents, including INDs, NDAs, FDA briefing packages and other essential US and global submissions documentation. This includes representing manufacturers with global regulators including the FDA and EMA. Moreover, we have substantial experience in the preparation of public and private payer dossiers that incorporate appropriate clinical, cost and/or comparative effectiveness data, as well as health technology assessments.
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