How FDA Blueprint Works
Strategic Advisor and Coaching
Guidance and mentorship of the team from the side to help them
prepare FDA regulatory submissions, handle quality issues and audits/inspections, and make critical timely changes to improve processes, structure, people and/or culture to get target results.
Fractional Leadership Support
Guidance and mentorship of the team together with hands-on leadership to achieve results and build your internal capacity to sustain growth. Note: Much like CFOs, early-stage companies do not typically need a full-time Chief Regulatory Officer.
Key Benefits
Expert
Guidance
Tap into decades of regulatory expertise to navigate complex FDA requirements with confidence.
Tailored
Support
Custom solutions for small to medium-sized enterprises, perfectly sized for companies with $2M+ funding and 5-100 employees.
Strategic
Relationships
Connect with industry leaders and regulatory experts to enhance your journey from concept to market.
Frequently Asked Questions
Find answers to common inquiries about FDA Blueprint.
What Services Does FDA Blueprint Provide?
We provide Regulatory, Quality, and Clinical Support for Your Medical Device or Combination Product
(Drug-Device or Biologic-Device), tailored for your specific needs.
How Do I Choose the Right Consulting Support?
It’s important to find consultants with a depth of experience and expertise ushering products successfully on to the market. In addition, our business model ensures better alignment with your needs as a business, and a greater degree of predictability in terms of outcome and cost.
What Is the Importance of Consulting Support?
If you have an experienced team, they will recognize the value of bringing in outside experts as advisors, and if you have an inexperienced team, we can bring both the expertise and interim leadership you need to get your products onto the market and also help you build the capabilities you’ll need for the long-term.
How Can I Guarantee That I Will Get Approved By The FDA?
While there is no way to guarantee any decision by FDA, the best way to position yourself for success is with a team of qualified experts, and we can help you build the right team and find the right experts.
How Can I Best Prepare For Interacting With FDA?
Whether you are preparing an FDA submission or expecting an FDA inspection, we have qualified experts who can meet with your team, work through your concerns, and help you put your best foot forward.
Can You Tailor A Support Option To Meet My Needs?
Regardless of the size of your organization, or the scope of your project, we have a variety of packages that can be custom tailored to your needs. Schedule a free consultation to discuss your plans with us, and we will work with you to outline the best support options to meet your desired goals.
How Can I Recover From A Negative FDA Interaction?
First, it’s important to understand that most situations or circumstances you might find yourself in with FDA can be improved. We have experience helping companies recover from warning letters, inspection findings, and all types of issues that can arise during a premarket review by FDA. We specialize in resolving these kinds of challenges, and the sooner you schedule an appointment, the more we can do for you, so don’t wait!
What Makes FDA Blueprint Different from Regular Consulting?
Regular consultants are experts that you can leverage for their knowledge and experience. At FDA Blueprint, we specialize in bringing both expertise and leadership to supplement your organization's needs, and provide that support within a predictable and affordable budget for small-sized startups and medium-sized growth companies.
+1 650.800.9784
FDA Blueprint Headquarters
4 Palo Alto Square, Palo Alto, CA 94306
Redding CA.Office
1755 East St, Ste B L5 Redding, CA 96001
FDA Blueprint is not affiliated with the U.S. Food and Drug Administration. FDA Blueprint and its contributors will not be liable for any errors or omissions in this information nor for the availability of this information. The owner and its contributors will not be liable for any losses, injuries, or damages from the display or use of this information.