REGULATORY STRATEGY
Sunrise Labs and Insight Medical Consulting: Your Partners in Innovation and Compliance
Sunrise Labs and Insight Medical Consulting have joined forces to support our forward-thinking clients in optimizing their journey to secure product marketing approval. Together, we provide a seamless pathway from development to commercialization.
Once your product is commercially available, we continue to add value by helping you maintain compliance with regulatory statutes and guiding you in shaping next-generation product concepts.
With our combined expertise, we’re here to help you navigate every stage of the medical product lifecycle, ensuring success today and into the future.
Let us know how we can support your vision!
Strategic Consulting
- Develop clinical/regulatory strategy to optimize process
- Clinical trial design to “fit” with regulatory pathway
- Clinical Study Report Generation
PreClinical Studies
- Benchtop Study Plans
- Animal Study Plans
- Interpretation of test results
- Guidance on addressing regulatory questions on testing
Due Diligence
- Evaluate business opportunities from a Regulatory/Clinical persepective
- Ensure unmet clinical need aligns with program and product value
Making Sense of Clinical Trial Results
- Interpret clinical Trial results
- Develop key messaging
- Risk/Benefit analyses
International Srategic Consulting
- Clinical and Regulatory Strategies
- World-wide clinical trial design
- PMCF program design
Regulatory Submissions
- PreIND
- PreIDE
- IDE
- IND
- 510(k) – De Novo 510(k)
- PMA
- BLA
Meet our Senior Clinical/Regulatory Advisor
Lauren Baker, PhD
Founder, Insight Medical Consulting
Lauren is a strategic advisor specializing in partnerships with clients through the product development life cycle. Before joining Sunrise, Lauren was CEO of Boston Biomedical Associates (BBA) which she founded to focus on the clinical research and regulatory affairs aspects of new medical products.
Strength through strategy
and transformation
Our agile project management is backed by years of experience across industry niches, revolutionary technologies, and organizations of all sizes.
Sunrise Labs doesn’t stop at the design stage. We are here to support your complete product life cycle.
Explore deeper insights on Regulatory Strategy
Check out our in-depth webinar recordings and articles to better understand our approach to regulatory strategy for medical devices and product development.
Discover Our Full Range of Expertise
At Sunrise Labs, we specialize in Regulatory Strategy. But that’s just one part of the story. From concept development to clinical readiness, our expertise spans every stage of medical device and life sciences innovation.