Combination Products

Combination Products Combination Products

At the forefront of innovation, our expertise in Combination Products sets us apart. Defined by FDA CFR Part 4, combination products represent a unique intersection of drug, device, and/or biologic elements, each bringing its own set of complexities and regulatory challenges. Navigating this intricate landscape requires a deep understanding of multifaceted regulatory requirements, along with the ability to seamlessly integrate diverse technologies and therapeutic modalities. Our team excels in synthesizing these elements, ensuring that your combination product not only meets rigorous FDA and global standards but also advances the frontier of patient care.

Understanding the criticality of these innovative treatments, we offer unparalleled support in the development and commercialization of combination products. Our approach is rooted in collaboration, leveraging cross-functional expertise in pharmaceuticals, medical devices, and biologics to drive the success of your project. From concept to market, we guide our clients through every step of the process, addressing technical challenges, regulatory hurdles, and market considerations with precision and agility. Whether you’re introducing a new product or enhancing an existing one, our comprehensive services ensure that your combination product achieves its full potential, delivering transformative solutions to those who need them most. Some of the deliverables we can help you with are specified below:

Design Controls

  • Design and Development Plan
  • User Needs and Stakeholder Needs
  • Design Inputs
  • Design Outputs
  • Design Verification & Design Validation
  • Test Method Validation
  • Trace Matrix

Risk Management

  • Risk Management Plan and Report
  • Design Failure Mode Error Analysis (DFMEA)
  • Process Failure Mode Error Analysis (PFMEA)
  • Use Related Risk Analysis (URRA)
  • Product Hazard Analysis (HA)
  • Risk Analysis Matrix
  • Clinical Risk Benefit Analysis (CRBA)

Design Transfer

  • Creation of Device Master Record (DMR)
  • IQ/OQ/PQ
  • Process Validation
  • Mold Approvals

Available resources specializing in Combination Products:

  • Project Management Professionals
  • Combination Products Engineers
  • Design Engineers
  • Product Development Engineers
  • Mechanical Engineers
  • Electrical Engineers
  • Software Engineers
  • Quality Engineers
  • Regulatory Specialists

Ready to get Started?

We provide our clients with Combination Product solutions though our Consulting, Staffing & Recruitment, and Outsourced Partner Services.

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!

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