Because of our unique set of skills, we can offer clients a wide range of services that go beyond regulatory consulting. And we will be there, working alongside you through every step of the process, even when the going gets really, really steep.

What we offer

Collaborate with you to develop a global regulatory strategy, and plans that align with your corporate goals.
Guide you through all the steps of the FDA pre-submission process from document development to agency review, meetings and follow-up.
Act as both your point of contact and advocate with regulatory agencies.
Work closely with you to create regulatory documents that are ready for submission to bodies around the world.
Train personnel on device regulations, including cGMP, design control, and industry best practices.

Assist you in developing a quality system that is FDA, CE IVDR, and ISO compliant.
Conduct internal audits of your quality system against FDA, ISO and MDSAP standards.

Facilitate the development of product development timelines from concept through launch.
Help you establish project management, design control and/or alliance management processes that meet the demands of regulators and your business.
Mentor your team on what is needed to be successful in the medical device industry.

Draft and review product development procedures, plans and protocols.
Development and review of verification and validation protocols, plans and reports.
Support you in working with competent authorities and agencies globally to fulfill the analytical and clinical study requirements for regulatory filings.