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 and Rx-to-OTC switch programs.
As a boutique firm, we provide personalized, dedicated attention — leveraging deep knowledge of FDA regulations including 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 and due diligence.
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 monograph modernization under the CARES Act.
MoCRA compliance, Drug Facts and Supplement Facts labeling, claims and advertising review, packaging artwork lifecycle management, EPR, Prop 65, CARB VOC, and state regulatory monitoring.
End-to-end submission support through OMORs, NDI notifications, cosmetic product listings, CDER Direct registrations, GMP guidance, pharmacovigilance, and lifecycle management.
Due diligence for acquisitions, M&A, and licensing; regulatory pathway assessments; ingredient safety and claims evaluation; and combination product classification.
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