REGULATORY
Solutions
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 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