End-to-end regulatory strategy and filing across the FDA, Health Canada, EU Notified Bodies, and EMA — plus stand-up of a right-sized quality system.
Registration, strategy, and submissions.
We define the regulatory pathway across the FDA, Health Canada, EU Notified Bodies, and EMA — including 21 CFR Part 4 combination-product logic and the correct lead center — prepare and run pre-submission meetings, and author and file the submission.
A QMS that fits your stage.
We stand up or remediate a quality management system compliant with ISO 13485 and 21 CFR 820 — right-sized to your company's stage, with the design controls, document control, CAPA, and supplier controls that hold up under inspection.
Let's define the strategy, submissions, and quality system your program needs.
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