REGULATORY

Solutions

We provide you with customized strategic and innovative regulatory solutions 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.

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Drug Development
Regulatory Solutions >

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Medical Devices
Regulatory Solutions >

Risk-Based Gap Assessments

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

Strategy and Planning

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

Submissions & Communications

We “speak FDA.” We help you communicate effectively with the agency.

Medical Device Approval

We assess the risk posed to the end-user to determine the class and regulatory path of your device.

FDA Meetings

Our experience in the planning and careful execution of FDA meetings ensures alignment with your company goals and well-defined regulatory expectations for your product.

U.S. FDA Representation

Are you a non-U.S. company needing an agent to represent you to the U.S. FDA? Rely on our trusted team to support your interests.

Medical Device Quality Management System

Our medical device QMS is validated for ISO 13485 and 21 CFR 820 compliance. Learn More

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