Regulatory Affairs

Regulatory Affairs

We specialize in helping companies create regulatory strategies and submissions, we have global experience in Medical Devices, Pharmaceutical Products, and Combination
Products. Some of the deliverables we can help you with are as follows:

  • Creation of regulatory strategy
  • Pre-submission meetings with FDA
  • CE Mark
  • NDA, BLA, and ANDA Submissions
  • 510(k) Submissions
  • Premarket Approval (PMA)
  • Clinical trial submissions (IDE, IND)

Available resources specializing in Regulatory Affairs:

  • Medical Device Regulatory Affairs Specialists
  • Combination Product Regulatory Affairs Specialists

Ready to get Started?

We provide our clients with Regulatory Affairs resources through our Consulting, Staffing & Recruitment, and Outsourced Partner Solutions.

Our Clients
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If you like what you see so far, just wait until we start talking. We can't wait to hear about your needs and then implement solutions to take your organization to the next level!

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What Our Clients have to say

“Ventura Solutions has been our strategic R&D consulting vendor since July 2017 and has been instrumental in the updating of our risk management quality system as well as authoring risk deliverables for our top projects. His consultants truly became an extended part of our organization as they quickly embraced our company culture, people, and processes to seamlessly integrate onto project teams. They share the same sense of passion to improve physician efficiency and patient satisfaction worldwide. and deliver on commitments with a high level of professionalism and quality. Ventura Solutions is an outstanding resource extension vendor that truly partners with you to exceed your business objectives.”

- Patrick Lee VP R&D Laborie Medical Technologies Corp.

“Ventura Solutions offers consultants with a rare blend of technical expertise + super communication skills. During combination product risk management and design control projects, A Ventura Solutions consultant was assigned as an SME to communicate to clients on very deep technical info as well as put together strategic insights. I would highly recommend Ventura Solutions consulting services for any engineering, quality or similar work.”

- David Amor CEO, Medgineering