Regulatory Affairs Services

Your regulatory strategy has one of the greatest impacts to your product's time-to-market, your pre- and post-market requirements, as well as development costs. The best strategy is also consistently monitored and updated as necessary. Our team can develop your regulatory strategy and make sure it meets your needs at every step along the way.

The labeling and promotional claims for your product have both pre- and post-marketing implications. Our team provides expert advice as well as hands-on assistance in labeling development, review, and management.

Fertility Clinics are some people's only option if they wish to have a family. In some cases, in order to make this dream come true for them, an Exemption Request needs to be submitted to FDA. Our team can expertly strike the balance between compliance and dream-making by authoring and submitting these requests to FDA on your behalf.

Our regulatory team can help advise, author, review, submit, and/or manage your pre-market submission, including Q-submissions, 510(k)s premarket notifications, De Novo applications, Premarket Approval (PMA) applications, and Technical File or Design Dossiers for CE marking.

Managing a smooth, effective meeting with a regulatory agency is imperative to ensuring an optimal outcome. We can strategize, author, and submit your meeting request, as well as help the team prepare for the meeting itself, including preparing the materials and conducting dry runs. Our team can also manage the meeting to ensure all agenda items are addressed to satisfaction within the time allotted.

At various stages of a product lifecycle, a regulatory assessment may be needed. Whether you're at the beginning of your strategy planning, or looking to make design, labeling or manufacturing changes post-market, our regulatory affairs team can help you navigate those muddy waters through a custom regulatory assessment.