What we do

End-to-end regulatory expertise across the product lifecycle.

From strategy and submissions through ongoing compliance and due diligence — we provide tailored regulatory support for OTC drugs, cosmetics, medical devices, and dietary supplements.

About the firm

A boutique approach to a complex landscape.

Envisage Consulting, LLC is a boutique firm offering specialized consulting services in Regulatory Affairs. 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.

Envisage assists clients with cosmetic compliance, OTC medical device and drug development, OTC monograph requirements, labeling, and advertising across all product categories. We provide regulatory strategy for OTC drug product development programs supporting monograph products, Rx-to-OTC switches, 510(k) submissions, and IND/NDA submissions — as well as due diligence reviews for mergers and acquisitions and regulatory assessments for business development and licensing opportunities.

As a boutique firm, we provide personalized and dedicated attention — leveraging our deep understanding of FDA regulations including OTC drug monographs, MoCRA, DSHEA, and the relevant 21 CFR requirements to help clients navigate complex requirements and ensure successful product launches and sustained market compliance.

DSHEA MoCRA OTC monograph modernization CARES Act 21 CFR 505(b)(2) pathways Rx-to-OTC switch 510(k) submissions IND / NDA FTC advertising standards
01

Strategy

Regulatory strategy development

  • Preparing regulatory strategies for nonprescription (OTC) drugs, cosmetic products, medical devices, and dietary supplements.
  • Advising on Rx-to-OTC switch processes, 505(b)(2) pathways, 510(k) submissions, and OTC monograph modernization under the CARES Act.
  • Providing claim substantiation for product, ingredient, and structure/function claims.
  • Guiding clients through FDA notification requirements, monograph compliance, and advertising review (FTC advertising standards) across all product categories.
  • Supporting FDA submissions including IND, NDA, and 510(k), as well as submission management for Annual Reports and PADERs.
02

Compliance

Compliance and labeling

  • Ensuring compliance with the Modernization of Cosmetics Regulation Act (MoCRA), including facility registration, product listing, safety substantiation, and adverse event reporting.
  • Ensuring OTC drug labeling compliance with Drug Facts panel requirements, approved monograph conditions, and post-marketing labeling obligations.
  • Developing processes for and managing packaging artwork lifecycle from concept through release, including cross-functional engagement with all stakeholders.
  • Assisting with dietary supplement labeling requirements under DSHEA, including Supplement Facts panels, claims substantiation, and required disclaimers.
  • Reviewing and developing labeling and advertising materials for regulatory adherence across OTC drugs, cosmetics, medical devices, and dietary supplements — including guidance on product claims, positioning, testing, and claims substantiation.
  • Ingredient compliance and specification review; compliance checks against retailer clean lists; California VOC compliance (CARB); Prop 65 review; and California Safe Cosmetic Program review and registration.
  • Assisting with state Extended Producer Responsibility (EPR) requirements and PROs across product categories, plus state licensing for wholesale/distributor needs.
  • Monitoring state regulatory developments and implementing necessary updates to ensure ongoing compliance.
03

Submissions

Comprehensive support

  • Providing end-to-end support through the regulatory submission process, including OTC monograph order requests (OMORs), NDI notifications, cosmetic product listings (FDA and state), and FDA correspondence.
  • Submitting and maintaining OTC drug registrations through the FDA's CDER Direct system, including updates in response to labeling and packaging changes.
  • Offering expert guidance on Good Manufacturing Practice (GMP) compliance for OTC drug and dietary supplement facilities, and cosmetic manufacturing best practices.
  • Supporting adverse event reporting obligations under applicable regulations for OTC drugs, cosmetics, medical devices, and dietary supplements — including pharmacovigilance and complaint handling support for Serious Adverse Event and Medical Device Reporting.
  • Offering expert guidance on maintaining compliance throughout product life cycles, including reformulations, line extensions, and post-market surveillance.
  • Managing and maintaining UPC assignments through the GS1 system along with overseeing packaging specification records.
  • SOP development and training to support sustained operational compliance.
04

Due Diligence

Due diligence & regulatory assessments

  • Conducting due diligence reviews for acquisitions and licensing opportunities across OTC drugs, cosmetics, medical devices, and dietary supplements.
  • Performing comprehensive regulatory assessments to identify potential issues, recommend solutions, and determine regulatory pathways — including assessments for business development and licensing opportunities.
  • Evaluating ingredient safety, permissibility, and claims support for OTC drug, cosmetic, and dietary supplement portfolios.
  • Assessing product classification and potential combination product considerations to ensure appropriate regulatory pathway selection.

Tell us about your project

Whether it's a single submission, an Rx-to-OTC switch, or full lifecycle support — we'd be glad to discuss how we can help.

Get in touch