We perform discrete tasks or lead comprehensive programs for your regulatory, quality and clinical requirements. We collaborate with your team to troubleshoot and achieve cost-effective and time-efficient solutions.
Results come from executable strategies.
We are accomplished strategists who work with all entities of the medical device industry. From policy to project considerations, we produce concrete successes for our clients. We support due diligence activities, perform strategic reviews and lead companies’ interface with regulators, investors and industry partners.
- Medical device companies
- Health/wellness/software companies
- Contract design and manufacturing firms
- Law firms
We support due-diligence for:
- Angel investors
- Venture capitalists
- Private equity firms
- Strategic acquirers
- Boards of Directors
We offer expert review and advisement. Our senior staff members also function as companies’ internal regulatory, quality and/or clinical representatives.
- Acting VP of Regulatory, Quality and/or Clinical Affairs capabilities
- Expert witness testimony
- Interim staffing solutions
- Sales training
We interface with:
U.S. FDA and CA FDB:
- CDRH Office of the Director
- CDRH Office of Device Evaluation (ODE)
- CDRH Office of Compliance
- Office of Combination Products (OCP)
- State of California Food and Drug Branch (FDB)
OUS Regulatory Agencies
- Notified Body
- Authorized Representative
- Competent Authorities
- Health Canada
- Pharmaceuticals and Medical Devices Agency
We need people who can become a part of the company in order to guide us through commercialization