Lauren Baker, PhD
Senior Clinical / Regulatory Advisor
Suntra MedTech Solutions and Insight Medical Consulting: Your Partners in Innovation and Compliance
Suntra MedTech Solutions 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.
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 strategic 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
