our services
From navigating MoCRA requirements and risk assessment to cosmetic registration and regulatory due diligence, we provide a variety of services to support your brand in the best way possible.
We stay up-to-date about the beauty, health and wellness industries and the regulations that govern them –
Learn more about how we can help below.
so you don’t have to!
On December 29, 2022, Congress passed the Modernization of Cosmetics Regulation Act - or “MoCRA”, as it is commonly known - and it is the most significant piece of legislation affecting cosmetics since 1938, when cosmetics was added to the Federal, Food, Drug, and Cosmetic Act. MoCRA increases federal oversight of cosmetic products and introduces new mandatory requirements for cosmetics, some of which went into effect as early as December 29, 2023.
As a manufacturer or brand founder, you have several responsibilities under MoCRA, including facility registration and product listing, but you do not have to go it alone! We can be your U.S. Agent – as part of the facility registration requirement under MoCRA, foreign facilities are required to provide their U.S. Agent contact information.
Modernization of Cosmetics Regulation Act of 2022
Make us your U.S. Agent
We can also be your
Canadian Responsible Person
"I have had the pleasure of knowing and working with Simone for over 10 years, watching her grow and develop as part of my corporate regulatory team into a leader in the consumer healthcare regulatory space. Simone is a dedicated and ethical professional, holding herself to the highest uncompromising professional and confidential standards. As CEO and Founder of Vogue Regulatory, Simone is an experienced and very knowledgeable regulatory affairs professional, who can offer keen insights into the regulatory compliance landscape. Her interpretive and application skills are excellent, giving clients comfort knowing the regulatory status of their products are in good hands. I have worked with Dr. Swafford for many years, both as a colleague and client, and am pleased to recommend her services."
David W. Grob, MS, RAC
Founder/Principal Grob Consulting LLC
"Simone is my go-to regulatory expert for US cosmetic and OTC-monograph support on both a federal and state level. Simone has a deep knowledge of the US regulatory landscape and is able to bring clarity to complex scenarios. I value Simone's knowledge, professionalism, collaboration, keen eye for details and support over the years and would whole-heartedly recommend working with her if you're planning to launch in the US market."
Kamal Kaur
Managing Director & Principal Regulatory Consultant, The Cosmetic Regulator
"Working with Simone from Vogue Regulatory has been an absolute pleasure. She supported us through ensuring all of our packaging was fully compliant for the U.S. market and helped us navigate the detailed requirements of large box retailers. Simone is always responsive, thoughtful, and thorough in her approach, striking the perfect balance between being commercially pragmatic and ensuring full regulatory compliance. Her expertise and calm professionalism made what could have been a complex process seamless and stress-free."
Maree Glading
Founder & CEO, Evre Self-Care Ltd (NZ) & Evre Self-Care Inc. (US)
"Working with Simone has been essential for our team. She brings deep expertise in skincare regulations and provides thoughtful, efficient reviews that are always grounded in the latest guidance. Her support gives us confidence as we develop and launch new products. Beyond her professionalism and knowledge, Simone is a joy to work with - kind, approachable, and consistently reliable. I recommend her without hesitation!"
McCall Stanier
Chief of Staff, Omnilux
- OTC Drug and Supplement Facts label creation
- NDC labeler code requests
- Drug Establishment Registration & Product Listing
- Canada Drug Identification Number (DIN) & Natural Health Product (NHP) submissions
Drug Registration & Listing
- New raw material qualification
- Individual ingredients and finished formula regulatory screenings
- Retailer compliance including Sephora, Ulta, Credo, among others!
Raw Material & Formula Assessments
- MoCRA Cosmetic Product Listing and Facility Registration
- California Safe Cosmetics Program reporting
- Canada Cosmetic Notification
- EU/UK Product Information Files (PIFs) compilation
Cosmetic Product Listing & Notification
- Modernization of Cosmetics Regulation Act (MoCRA)
- Federal and state legislative changes
- International regulatory updates
- Other cosmetic/OTC drug/dietary supplement regulatory-related issues
Regulatory Intelligence & Monitoring
- Label compliance and ingredient list reviews
- Advertising claims and substantiation guidance
- Regulatory risk assessments for new product concepts and promotional materials
- Updates on recent enforcement activities (FDA, FTC, NAD, etc.)
Advertising & Labeling Review
While there is no one-size-fits-all approach to safety, under MoCRA, brands are required to have documented safety substantiation for their products and sometimes clinical testing is not always financially feasible. Ask about our MoCRA safety substantiation dossier packages!
Safety Substantiation
Here’s what it looks like to get started working with us:
Next, you’ll receive a consulting agreement and once executed, I get to work!
getting started
Then, I send a consulting proposal that details the work we'll do together and how our process works for your review and approval.
proposal
We start with a 30-minute introductory call so I can understand your regulatory needs and see if we’re a good fit (plus answer any questions you have!)
intro call
Our Process
in navigating regulatory matters, so you can focus on growing your business.
We want you to always understand what’s happening and why, plus have someone you trust to come back to anytime there’s a grey area or you need support navigating a new requirement.
