avoid development delays and costly mistakes. We work with you to develop and implement strategies that are right for your organizational infrastructure, product risk and budget

Providing an Integrated Team for Enhanced Efficiency in Your Strategies and Operations

Founded in 2001, Lincé Consulting is dedicated to supporting companies ranging from small start-ups to large established corporations. We specialize in Regulatory Affairs, Quality Assurance, Clinical Affairs and Project Engineering offering a cohesive team to meet the diverse needs of our clients.

Nancy Lincé, the founder of Lincé Consulting, identified a major and costly inefficiency in her clients working process; namely the outsourcing of their regulatory, clinical, quality and project engineering needs to different consultants or groups absent of clear oversight and management. Convinced that a turn-key consultancy was in the best interests of her client base, Nancy went on to greatly expand the company’s consultant network enabling Lincé Consulting to assemble the perfect team essential for the success of any medical product manufacturer in the global marketplace.

Our team consists of professionals with over 450 years of combined experience who partner with our clients, tailoring our services to their unique infrastructure and requirements and ensuring the success of their regulatory, quality, clinical and project engineering goals in the most efficient way possible.

Dedicated to establishing and implementing the most effective strategies
to meet client milestones

Our Approach

Lincé Consulting embraces a professional and customer-oriented approach. Our dedicated team is attentive to your needs, meticulous in our approach, and committed to providing optimal solutions tailored to your specific requirements.

Full Accountability

We act as an integral part of your team, providing comprehensive support and unwavering dedication to the quality of our work.

Hands-on Partner

We are prepared to participate actively and make meaningful contributions to achieve your objectives.

How We Work

In addressing challenges, our management team swiftly identifies suitable individuals or experts from our extensive team. We meticulously choose experts whose skills and knowledge align with your specific requirements, ensuring that we have a highly experienced team available and fully equipped to address any regulatory, clinical, quality and project engineering needs your company may encounter.

Seasoned Experts

Leverage our expanding team of experts with over 450 years of collective experience working in the dynamic field of innovative medical product development. Each team member contributes extensive expertise and valuable connections to enhance the success of every project.

Tailored Solutions

Our team is dedicated to developing practical solutions to meet client milestones efficiently and cost-effectively, from the initial concept to the post-marketing stages.

Our Value Added

We have a proven history of effectively interpreting, addressing, and resolving intricate challenges and finding effective solutions within the complicated landscape of regulatory and clinical approvals and quality compliance and project engineering.

Up-to-Date Information

We remain up to date on the most recent regulatory, clinical and quality changes to ensure we can expertly navigate you through the ever-changing business landscape. Our commitment to staying current enables us to provide seamless guidance in this dynamic environment.

Strong Relationships, Knowledge and Understanding

Bringing a wealth of expertise cultivated through years of successfully navigating negotiations and engagements with the FDA and international regulatory agencies, our team's extensive experience is a testament to the depth of knowledge we have developed over time in the industry.

End-to-End Services

Experience the advantage of a unified team supporting you every step of the way through the entire product lifecycle, increasing efficiency, cost savings, and expediting time to market with our cohesive and dedicated approach.

Meet the Founder

Nancy Lincé, the founder, president and CEO of Lincé Consulting, personally manages all incoming projects. She carefully selects the team for your needs based on the specific requirements of each project, ensuring that each member possesses extensive expertise and experience in the relevant field.

Nancy M. Lincé

President and CEO

Starting in the medical device industry in 1992, Nancy has over 30 years of experience in regulatory, clinical and quality affairs spanning a wide range of products including innovative medical device, IVD, combination and drug delivery products and pharmaceuticals.

Before starting Lincé Consulting in 2001, she worked in a variety of regulatory, quality and clinical affairs capacities for companies including Origin Medsystems (which was part of Eli Lily, Guidant and then Boston Scientific and Abbott Labs), Conceptus (a Target Therapeutics spin-out) and as Vice President of Clinical and Regulatory Affairs at Eclipse surgical technologies, a company focusing on cardiac surgery and cardiovascular applications.

Memberships & Additional Industry Involvement

  • Member of Regulatory Affairs Professional Society (RAPS)
  • Regulatory Affairs Certification (RAC)
  • B.Sc. in Business Management
  • Regulatory advisor and coach for Stanford Biodesign Innovation program since 2016
  • Regulatory advisor and coach for Hospital Israelita Albert Einstein, Brazil since 2022

Our technical expertise at your service