Case Studies + Testimonials

A first-hand look at working with Suttons Creek

Now offering a wider scope of benefits as a proud member of the ToxStrategies family of companies.

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Case Study: Organizational Roadblocks

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Case Study: Strategic Alignment

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Case Study: Regulatory Strategy

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Case Study: Device Platform Selection

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Case Study: Premarket Regulatory Issues

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Case Study: Vendor Relationship Management

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Case Study: Vendor Systems Readiness

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Case Study: Design + Development Pivot

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Case Study: Risk-Based Test Method Strategy

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Case Study: Partnership Assessment

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Case Study: Strategic DHF Development

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Global Biotech | CEO

We feel that the outcome was positive, setting us on the proper path to move forward towards our FDA submission. This being my first entry into the Medtech world, there were many times I was unsure of next steps, approaches and actual outcomes needed. Your team helped me understand the complexities of this process.

Leading Biotech | Global Regulatory Head, CMC

Thanks for your partnership, expertise, and excellent quality of work. I particularly appreciate that you helped navigate a three-way conversation amongst the parties involved and helped us all move forward with a reasonable approach.

Global 200 Pharma | Executive Director, Device Quality

We recognize the value that Suttons Creek has brought to our team. I frankly do not know how we could have achieved the goal without your help.

S&P 100 Pharma | Director, Regulatory Affairs

You guys are the organization that is REALLY helping Pharma companies bridge the gap.

Big Pharma | VP, Device Development

Suttons Creek really saved our [bleep!] on this one.

Fortune 200 Pharma | Director, Reliability, Risk Management & Design Assurance

Thank you and the team for the attention, diligence, focus and understanding of our crazy timeline!

Small Pharma | Senior VP

Thank you for all of the critical support you’ve provided and for jumping in with a 110% commitment to helping us navigate this fire drill at all hours of the day! I know there’s still a lot of work ahead but getting a high quality 483 response document out today was a huge milestone and your contribution to this was vital.

Clinical Stage | VP Device Development

You rock Rock I truly appreciate your contributions – We’re moving at warp speed and your experience, tact, and commitment have been critical to the progress we’ve made.

Small Pharma | Associate Director, Clinical Quality Operations

SCI’s support has been integral in expanding our knowledge into the device space, as well as supporting us when we need on-site training.

Startup Pharma | CEO

Is this the point at which you should tell us, “we told you so”?” Thanks for your help on our FDA audit!

Startup Pharma | CEO

Suttons Creek exceeded expectations…indeed. However, I am not sure I was clear what the expectations were in the first place [due to] my lack of experience in this arena. I am sure that your team realized our adolescence and formed their approach appropriately. It was appreciated.

Small Pharma | CMC

Yes, [SCI has] added a lot of value and has also been very flexible as our business priorities shifted over time, which we appreciate very much!

Clinical Stage Biopharma | Head of Drug Product Dev.

[Suttons Creek’s work] was very satisfactory. And Rob Exceeded Expectations! Thank you so much for your time and support on this project. We’re so glad to have made this connection!

Leading Device OEM | Director, Regulatory Affairs & Intelligence

We continue to have a great experience with the SCI team and especially your regulatory experts.  Suttons Creek continues to exceed expectations. We are looking forward to receiving the new contract for next year!

Biotech | CMC Lead

I would give Suttons Creek a very hearty “satisfactory” rating. It would have been “exceeded expectations” but I already knew how good the team was.

Big Pharma | Executive Director, Device Quality

We would not have gotten this project out on schedule without the leadership of Suttons Creek.

Publicly Traded Biotech | SVP, Quality

Suttons Creek has been a trusted partner who truly understood our business needs. Our statement of work goals and needs were met and I feel we definitely got our money’s worth. I was impressed with their level of customer service and professionalism.

Leading Device OEM | Sr. Director, Regulatory Affairs

Suttons Creek exceeded expectations – Wow, I had no idea that the SC team would be this good!

Medical Device Company | Director of Corporate Development

We got just what we were looking for with the Sutton’s Creek engagement.  Courtney and Carolyn were excellent partners…we had very high expectations going in and they were met.