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Novo Compliance’s Regulatory Sciences (RS) in Life Sciences

Includes Novo Compliance’s Regulatory Strategic ARC® Frameworking and Methodologies

Regulatory Sciences is the discipline that underpins the development, evaluation, and oversight of medical products through scientific methods. It bridges the gap between innovation and regulation, ensuring that therapies are safe, effective, and reach patients efficiently.

Novo Compliance’s Regulatory Sciences (RS) in Life Sciences

Includes Novo Compliance’s Regulatory Strategic ARC® Frameworking and Methodologie:

  • Developing tools, standards, and approaches to assess product safety, quality, and performance.
  • Evaluating emerging technologies like gene therapies, nanomedicine, and AI-driven diagnostics.
  • Informing policy and guidance through evidence-based research.

Faq's

Includes Novo Compliance’s Regulatory Strategic ARC® Frameworking and Methodologies

Clarifying Complexities, Advancing Interdisciplinarity, Reproducibility, Sustainability and Continuous Innovations throughout client’s end to end lifecycle

In the life sciences, “frameworking” (or the process of developing and applying frameworks) develops essential and the fundamental architecture organizing complex biological, ecological, and health-related phenomena into structured, interpretable models.

  • Biomarkers & Surrogate Endpoints – Accelerating clinical trials and approvals.
  • Modeling & Simulation – Predicting outcomes and optimizing trial design.
  • Real-World Evidence (RWE) – Using post-market data to refine regulatory decisions.
  • Advanced Manufacturing – Supporting continuous and personalized production methods.
  • Digital Health & AI – Evaluating software as a medical device (SaMD) and algorithmic transparency.
  • Novo Compliance’s commitment to our Sponsors, Healthcare Practitioners and Patients driven through our Mission, Vision and Purpose and most importantly, why this matters-

Regulatory Science is championed by global health authorities including:

  • FDA’s Office of Regulatory Science
  • EMA’s Regulatory Science Strategy
  • PMDA’s Science Board
  • WHO’s Innovation Platforms
  • JPDA, PMDN

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