“Working with Mittal Consulting has been a tremendous asset to Xylexa. Their team brought deep regulatory insight and hands-on guidance that was directly aligned with Xylexa’s technology, clinical strategy, and FDA objectives. They played a key role in helping us prepare for and successfully engage with the FDA, even under complex and time-sensitive conditions. What stood out most was their dedication to Xylexa’s success, their responsiveness, and their ability to translate complex regulatory requirements into clear, actionable steps for our team. Mittal Consulting has been a trusted partner at critical milestones, and we value their support throughout this journey.”

“Working with Mittal Consulting has been an exceptional experience. Their regulatory insight, responsiveness, and attention to detail throughout our FDA pre-submission process were truly outstanding. Kristen Mittal and her team not only guided us with clarity and precision but also demonstrated an impressive understanding of both the scientific and strategic aspects of our project. Their professionalism and commitment have been instrumental in achieving a high-quality, timely submission, and I can recommend them without reservation to any medical device company navigating complex U.S. regulatory pathways.”

  “We have engaged with Mittal Consulting since June 2024. 3D Orthobiologic Solutions is an early-stage company focusing on bone graft technology for surgery and 3-D cell culturing platforms. Mittal has worked with us our FDA regulatory assessment and strategy and our Pre-Submission document for our first product. We have found their guidance and input on the regulatory process extremely thorough and detailed. Their commitment and value added to our company has been excellent.”

    “I would say it’s been a wonderful experience. Kristen, Shu and team have been extremely professional and met all of our expectations on coming up to speed with the device area, supporting information and research you conducted, and applied your past knowledge and experience to help shape the critical topics of the submission. All in all, I would highly recommend (and will use again) your consulting services”

  “We feel incredibly fortunate to have met Kristen and her team. We are an early-stage startup with multiple medical devices, both hardware and software, in development. Before we even agreed to work with them, they reviewed all of our prior regulatory history including multiple meetings with the FDA, and key publications, allowing them to propose a realistic and informed schedule. The whole team has been professional, prompt, and helpful. 100% recommend”