Consulting & Strategy Solutions

Regulatory & Strategy Consulting

FDA IDE/PMA, IND/NDA/BLA, Orphan & QIDP; EU MDR/IVDR; Health Canada; TGA (Australia).

Navigating today’s evolving regulatory landscape requires both rigor and foresight. Nor Consult provides strategic guidance across U.S. FDA (IDE, PMA, NDA/BLA, CVOT) and EU MDR/IVDR, Health Canada and Australia Therapeutic Goods Administration (TGA) pathways. Our experts bring direct experience supporting successful submissions and sponsor–FDA interactions, ensuring your program is audit-ready and positioned for global adoption.

Biometrics & Clinical Epidemiology

We bridge cutting-edge biometrics with advanced clinical epidemiology to deliver precise, data-driven insights that drive smarter decisions in clinical development. Led by Dr. Branko Kopjar and supported by senior biostatisticians, our team specializes in rigorous study design, statistical programming, and interpretation of complex health data.

By combining innovative statistical methodologies with real-world epidemiological expertise, we provide:

• Regulatory-ready deliverables: SAPs, interim/final analyses, DSMB workflows, CDISC-compliant datasets.
• Evidence-based trial design: optimized endpoints, time-to-event methods, bias control, and registry/RWE integration.
• Strategic insight: actionable results that resonate with regulators, payers, and clinicians.

This integrated approach accelerates development, ensures scientific accuracy, and
strengthens go-to-market strategy for pharmaceutical, biotech, and medical device
sponsors worldwide.

Investor Strategy

Independent diligence reviews to help investors assess development risks and startups demonstrate readiness to secure capital. For investors and emerging companies alike, clinical and regulatory preparedness is a critical differentiator. Nor Consult provides objective diligence reviews, assessing therapeutic pipelines, development risks, and regulatory strategy. Our insights, supported by decades of trial leadership and FDA experience, help investors deploy capital with confidence and position startups to demonstrate value to partners.

Expert Witness

Dr. Branko Kopjar and others in our network of physician-scientists bring a rare blend of scientific rigor and clear, compelling communication to the courtroom. With deep expertise in various medical specialties, clinical trial design, healthcare reimbursement, statistical analysis, and epidemiological methods, we translate complex health and data-driven evidence into clear, unbiased testimony that withstands scrutiny. Whether evaluating clinical trials, (public) health data, or statistical models, our experts provide objective, evidence-based opinions that help legal teams illuminate the truth and strengthen their case. Our role is not only to analyze data with precision but to present it in a way that judges and juries can easily understand—bridging the gap between science and law with credibility, clarity, and authority. We have supported law firms pursuing class action litigation in the United States and consulted for one of the “Magic Circle” U.K. law firms.