“We are providing comprehensive expertise to the healthcare industry. We offer integrated end-to-end services starting with your medical product idea and until your product is approved with adequate reimbursement coverage. Our focus is to offer a pragmatic solution that works best for your company and your products.
Regulatory Strategy
Next Regulatory specializes in developing innovative and holistic regulatory strategies tailored to the unique needs of our clients. Our approach begins with a comprehensive analysis of applicable approval pathways, including requirements from marketing and market access and identifying costs, timeline, risks and opportunities, ensuring full transparency and sufficient information to allow the management to make an informed decision.
We recognize that each client’s goals are unique, requiring customized solutions, this is why our regulatory strategies are designed not only to meet compliance requirements but also to support the overall business strategy. Our focus is to deliver a comprehensive, clear and robust plan for timely product introduction.
We provide regulatory strategy for new product introduction, territory expansion, and global market approval.
Reimbursement
At Next Regulatory, we see beyond market approval and we incorporate market access in the early stage of the product development, ensuring that reimbursement can occur simultaneously or shortly after product approval. The intended use and use case scenarios are tailored to heighten the probability to get suitable coding and reimbursement. By engaging in early discussion with regulatory agencies, coding organization and public and private payer, we ensure proper product positioning, adequate data collection during the product development and a clear view of possible product pricing and costs for users/patients.
Regulatory Intelligence
At Next Regulatory, we truly resonate with the principle of “Scientia potentia est” (Knowledge is power), this is why we offer comprehensive regulatory intelligence services. By closely monitoring regulatory shifts and conducting in-depth analysis, we help our clients to stay ahead of industry changes, ultimately driving better outcomes in their regulatory affairs initiatives. This proactive approach to regulatory intelligence allows us to synthesize data into actionable insights.
Our team stays abreast of legislative updates and policy changes, ensuring that our clients receive timely information about the evolving regulatory landscape. This holistic view supports organizational objectives, enabling businesses to adapt quickly to changes in the regulatory environment while maintaining compliance with relevant standards.
Process Optimization
Next Regulatory is helping mapping current regulatory workflows, identifying bottlenecks, broken links, blurry interfaces and possible update. We work collaboratively with organizations to optimize their processes, thereby reducing the time required for regulatory submissions and ensuring a thorough understanding of compliance obligations.
Ad-hoc Consulting Services
Hourly Consulting
Workshop Facilitation
Training Session
Internal Audit
Documentation Review
Curated Templates
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