We provide a customized regulatory solution and a dedicated team throughout the life of the project based on your needs and stage of development. We help you navigate the complex and evolving regulatory environment to facilitate successful and timely Agency interactions and submissions.

Build a successful regulatory path for your technology.

Regulatory Strategy and Planning

Our regulatory services to help minimize product development time and accelerate product approval by providing guidance and solutions to regulatory hurdles.

FDA Meetings

The planning and careful execution of FDA meetings will ensure alignment and define your requirements.

Submissions & Communications

We “speak FDA.” Allow us to help you best communicate with the agency.

Medical Communications

Medical Writing

Leverage our expertise to writing, submit, and manage communications with clinicians, regulators and stakeholders.
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Medical Device Approval

The risk posed to the end-user will determine the Class and regulatory path of your device.

U.S. FDA Representation

Do you need an agent to represent you to the U.S. FDA? Rely on our trusted team to support your interests.

Risk-Based Gap Assessments

A risked-based gap assessment identifies the gaps in product development, CMC, and analytic and safety testing requirements.

Quality Management System

We provide a validated QMS that is ISO 13485 and 21 CFR 820 compliant. Learn More

From Discovery to Commercialization…
What innovative thinkers do in detail.