- Together we innovate.You develop transformative medical devices.
We develop strategies that work.
- Expert PartnerWe are your senior strategist,
Acting VP or regulatory representative.
- Regulatory AffairsWe define the pathway
and deliver your major milestones.
- Quality SystemsWe ensure your compliance through
a customized approach.
- Pre-Clinical & Clinical ResearchWe design and run your studies to
produce high quality data.
- Biostatistics & Data ManagementWe ensure data accuracy for your
Right path. Right strategy. Right partner.
Headquartered in Silicon Valley, our clients range from medtech
startups to industry giants. We integrate appropriate regulatory,
quality and clinical perspectives at all stages of the product life cycle.
Technology drives us. We lead programs for the most novel devices, IVDs, combination products, and mobile apps that are transforming medical care. Our experience covers every major area of clinical practice. Our involvement encompasses first-of-kind products as well as innovative, next generation technologies.
Results speak for themselves. We maintain exceptional clearance and approval rates for our clients’ U.S. and OUS premarket applications. We manage multiple submissions and lead numerous audits each and every month, covering a wide array of technologies. Our clients’ outcomes serve as our performance metric.
Intellectual property defines companies. Our business requires your utmost protection. Client proprietary information and privacy are rigorously maintained at all times. We strictly protect confidential information in all elements of our work.
Events to connect
We recognize the value of industry relationships and shared knowledge.
Whether presenting, participating on panels or attending to engage on
critical topics, we look forward to each opportunity to strengthen our
firm and contribute to the broader medical device ecosystem.
Getting solutions to patients can be a long and complicated process. Working with the FDA is a key part of the sequence. Preparing for and understanding the FDA's needs is essential to smooth the way and shorten your time to approval.
Johnson & Johnson Innovation, JLABS is happy to be hosting Ron Farkas, MD PhD, Vice President, Technical, PAREXEL Consulting, to discuss the ins and outs of FDA meetings. Ron will pull from his vast experience which includes a decade plus run at the FDA to help guide us through these vital interactions. Topics will include:
Understanding the FDA's position; not just what it wants but why
What to agree on now and later; What does agreement mean?
The key to proceed
Understanding the dynamics within the FDA
Flexibility and norms and what they mean
Experts, Patients and Advocates at Meetings
Meeting minutes and follow up
Understanding the process will help you better prepare for your meetings and build confidence in and ability to adjust your own plan. Come prepared with your questions!
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