FDA regulatory affairs
A boutique consultancy specializing in regulatory strategy for over-the-counter drugs, cosmetics, medical devices, and dietary supplements. Personalized expertise. Proven outcomes.
Our approach
Envisage Consulting, LLC is a woman-owned boutique firm offering specialized regulatory affairs consulting. We assist clients with marketed nonprescription drugs, cosmetic products, medical devices, and dietary supplements — and provide regulatory support for product development programs including Rx-to-OTC switch programs.
As a boutique firm, we provide personalized, dedicated attention — leveraging deep knowledge of FDA regulations including OTC monographs, DSHEA, MoCRA, OTC monograph modernization, and 21 CFR requirements.
Learn more about what we do →What we do
End-to-end regulatory support across every stage of the product lifecycle — from strategy and submissions through compliance.
Regulatory strategies for OTC drugs, cosmetics, medical devices, and dietary supplements — including Rx-to-OTC switches, 505(b)(2) pathways, 510(k) submissions, IND/NDA support, and OTC monograph, including OMOR submissions.
Drug Facts / Supplement Facts labeling, monograph compliance, claims and advertising review.
End-to-end submission support for NDAs, INDs, OMORs, CDER Direct Registrations, cosmetic product listing.
Due diligence for acquisitions, M&A, and licensing; regulatory pathway assessments; ingredient safety and claims evaluation.
Why a boutique firm
"Personalized, dedicated attention — leveraging deep understanding of OTC drug monographs, MoCRA, DSHEA, and the relevant 21 CFR requirements to ensure successful product launches and sustained market compliance."
Whether you're preparing a launch, navigating a switch, or evaluating an acquisition — let's talk.
Contact us