Services

Confiance Cosmetic Group is a trusted and dedicated regulatory and quality partner for developing cosmetic, dietary supplement, and medical device products. Whether you're embarking on a new product journey or enhancing an existing one, we provide invaluable expertise and support in the United States, the European Union, and across the globe. We offer support and consultancy services for cosmetics, medical devices, and dietary supplements.

Your brand’s compliance partner

The law does not identify tests or documentation to substantiate your products’ safety. Our qualified experts evaluate the safety of your products and ingredients to prove the product meets existing safety standards. We assess your ingredients and products against the EU safety standard.

Additionally, you will receive a Cosmetic Product Safety Report (CPSR) established in accordance with the European Cosmetics Regulation EC No 1223/2009 to substantiate cosmetic product safety in the United States, the EU and the United Kingdom, giving you an economical solution to help your business grow.

Modernization of Cosmetic Regulation Act (MoCRA)

We provide a variety of services to assist our clients with MoCRA compliance efforts, including:

Adverse Events: Reviewing recordkeeping procedures, designing and implementing adverse event receiving procedures and working closely with your customer service teams. Confiance is familiar with Gorgias, Zendesk, Gladly and other CS services.

Facility Registration: Let Confiance act as your designated U.S. agent to assist with FDA internal policy compliance including FEI registration and Cosmetic Direct registration.

Product Listing: Handling UNII requests and regulatory services related to the registration of your cosmetic products, which are required 120 days prior to product marketing.

FDA Enforcement: Conducting recall procedures analysis, developing strategies in line with current FDA requirements and assisting with future enforcement actions your facility may face.

Safety: Review current formulations for compliance, proposing testing plans, creating Product Information Files (PIF) and identifying strategies for new product development.

Good Manufacturing Practice Requirements: Conducting full audits of your recordkeeping and procedures, performing gap analysis against current ISO standards and assisting in creating processes and procedures on a per-project basis cost.

If you are working with contract manufacturers, we offer audits of your manufacturing partners’ current GMPs and capabilities and audits against company standards or requirements that are important to you and your business.

Ingredient, Label Review & Product Registration

We help you create harmonized labeling solutions for the United States, Canada, Europe and other international markets to help you save money, time and energy, including:

Ingredient review for California Proposition65, the California Safe Cosmetics Act and other regulations.
Online and in-store compliance review for website and marketing materials claims.
U.S. FDA OTC and Canada NPN/DIN Drug Facts labeling review, monograph compliance review and product claims review.
OTC product registration
Canada NHP drug registration and importer of record services
California Safe Cosmetic Act registration
Medical Device Registration (Class I & II)

Consulting

General consulting services (hourly and retainer)
Raw Material consulting
Retailer relationship management (regulatory and quality)
Expert Witness

Auditing Services

Confiance Cosmetic Group can provide comprehensive support in conducting follow-up audits of your suppliers and evaluating the implementation of your Corrective and Preventive Action (CAPA) plans. With our assistance, you can effectively assess the performance and adherence of your suppliers to ensure the successful execution of your CAPA initiatives.

We offer valuable insights and guidance to help you monitor and enhance the effectiveness of your supplier management processes, thereby promoting overall quality and compliance within your organization.

We work with global partners to support your auditing, no matter where it is in the world. We have certified auditors with accreditations for ASQ, NSF, ISO, and more!

With extensive OTC experience, we can help guide you through the quality development and planning stage through on-market compliance. We have worked with CMOs for their qualification of the manufacturing equipment and sanitation protocols, as well as work with independent labs for stability validation studies.

M&A Due Diligence

Whether you are selling or buying, we can support you with the compliance of the product portfolio, a crucial factor in the valuation of an asset.

Thorough regulatory due diligence and an extensive acquisition audit are essential when identifying and

evaluating your target's regulatory compliance and potential.

It is crucial to examine and assess your target’s regulatory landscape, ensuring that all necessary regulations and requirements are met. This diligent approach will provide valuable insights and help mitigate potential risks and liabilities associated with regulatory noncompliance.

With conducting a comprehensive regulatory due diligence and acquisition audit, you gain a deeper understanding of the regulatory environment in which your target operates, enabling you to make informed decisions and strategic moves that align with regulatory requirements and best practices.

Confiance’s expertise and experience enables us to identify departures from regulations and help correct them.

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