Make new, compliant personal care products for the US and Canadian Markets

Companies should start involving regulators in the earliest stages of product development. Your product will achieve wide acceptance in the market and make a profit only if each stage of your development process is carefully planned and reviewed beforehand.

Involving regulators during early development phases will protect you from having to effect costly reformulations, regulatory refusal, recalls and lawsuits. 

Our support is tailored to your business needs and facilitate the design and production of market-leading personal care products. We help with product presentation, marketing, advertising, claims review, country-specific regulatory issues and registration. 

Expand the market for personal care products

Compliance challenges persist even after a product hits its target market, because market expansion, new advertising and formulations require the prior approval of regulators. If you expand to a new country, you must overcome the regulatory challenges unique to your new market. 

Mitigate regulatory risks in acquisitions

Mergers and acquisitions can result in regulatory inconsistencies, decreasing the profitability of entire product lines or lines of business. The unique claims that power the sales of your product may not apply to your new acquisitions, and even their production processes may need a thorough review. 

It is best to create a risk assessment that evaluates how your potential acquisition stands vis-à-vis regulators. Risk assessments can foresee all the fallout from a new acquisition, from failed sales, recalls, lawsuits and stock value drops to investor distrust and product-related complaints. 

We make sure that you have all the facts at your disposal before you acquire a company, and our risk assessment can also help you negotiate a better price for your acquisition. 

Make unique claims based on top-class trials

Your product stands out in a highly-competitive market only on the basis of its unique claims. We can guide you in designing and implementing the clinical trials necessary to support claims appropriate for cosmetic products, and such studies will build your credibility, increase brand recognition, ensure consistent sales and even give you a reputation for innovation. 

prophema can also help you devise small-scale studies that enable you to make the highly-specific product claims, and execute these studies with the appropriate demographics. After the study is conducted, you will receive a report that assesses your product’s efficacy in the test-cases you specified, and we will also guide you on making your specified claims while remaining compliant. 

Product Classification & Confirmation
Ensure that you remain compliant in different jurisdictions by classifying your product as per each of your target markets.
Ingredient Restriction & Limitation Assessment
Know beforehand if your ingredients are accepted in your target market.
Required Warnings
Ensure that you include all the risks involved in consuming your product. Such warnings are required by regulations such as California’s proposition 65.
Ingredient Safety Review & Assessment
The use of novel ingredients in cosmetic formulations requires a review and safety assessment to mitigate any risks associated with these ingredients.
Cosmetic testing recommendations for specific claims
Cosmetic companies constantly seek to make new claims that can target specific demographics or consumer preferences. We help you identify the type of testing needed to substantiate specific claims such as Gluten-Free, Long-Wear and Free Form.
Requirements and validation for targeted product claims
Claims made about the absence of additives or allergens in your product need to be substantiated by laboratory testing, which should also confirm that your product does not wear off before its specified duration of effect, and that it improves a given baseline to a specific degree.
Guidance on compliance issues relating to GMPs
Regulations regarding good manufacturing practices are less rigorous for cosmetics than for drugs, but such products must still meet their regulatory standards. We review your extant standard operating procedures and practices to identify problem areas, especially those that have caused product quality issues.
Stability Protocol Development
Cosmetics need to be durable, especially as they may be shipped abroad, and it is hence best to devise stable formulations. Our stability protocols cover a wide array of cosmetic products and we ensure your products retain their quality based on their expiration date.
WERCs system—review and guidance for submissions
In the US, many retail companies employ third-party oversight to guarantee product safety, as pre-market authorization is not required in the country. We can help you through the WERCs process, identify areas that may need improvement in order to meet specific retailer requirements, and ensure that customers trust your product formulations and safety claims.
Assistance in registering products in the Voluntary Cosmetic Registration Program (US)
The FDA encourages companies to register products under the Voluntary Cosmetic Registration Program. Although not a requirement to sell in the US, we can help you with this program if you wish to be more transparent regarding your ingredients and formulations.
Warning Letter Mitigation
Though cosmetics in the US are not subject to pre-market review, the FDA can issue a Warning Letter if they find a product that violates regulations. We can help mitigate the ill effects of such a letter and ensure your product meets regulatory requirements so it can return to market as soon as possible.
Ingredient Listings
Transparency is paramount in listing ingredients in your labels. We can advise you on both the compliance and advertising aspects of your product labeling.
Compliant and accurate French translations
prophema offers French translation services for all labeling, advertising and marketing collateral for companies looking to operate in Canada.
Formula review & development (for ingredient compliance)
Your product stands out best if it is formulated based on the unique claims you plan to make. We will advise you on the ingredients, and their appropriate levels in your product composition to ensure your claims are acceptable.
Compliant Advertising Strategies
Compliance plays a role in all the aspects of unique claims, from product labels, marketing materials and advertising campaigns to website information and social media posts. This is why we give you a comprehensive compliance strategy for all aspects of product marketing, and also offer training for promotional agents so that they can market your products effectively, and respond to consumer queries in a compliant manner.
Review of data & studies that support your claims
Simple cosmetic claims often require little more than a thorough review of studies, data and other existing information. We help you prove basic product claims and advise you on how to make evidence-based additional claims.
Dual Canada-US cosmetic label development
The similarity between Health Canada and FDA regulations for cosmetics makes it possible to create labels compliant in both countries, which reduces product packaging costs, facilitates expansion into additional markets and widens brand recognition.
Cosmetic testing recommendations for compliance/spec development
Testing your finished product is vital to ensuring quality, and every batch produced must be tested for quality. We advise you on which tests are necessary and which can be foregone, and review after testing results for more recommendations.
Cosmetic Notification Form (CNF) prepation and submissions (Canada)
All cosmetics intended for sale in Canada need to undergo an online notification process and be registered with Health Canada. We ensure that all products, from companies both within and outside Canada, enjoy a smooth entrance into the Canadian market.
Assistance with third-party industry certifications
Increasing consumer demand for ethically-responsible products has led to the rise of third-party organizations authorized to issue industry certifications. We help you meet the standards required to acquire these certifications.
Notarization for Certificate of Cosmetic GMP Compliance Issuance
prophema offers Certificates of Free Sale issuances under the cosmetic product category for any company that imports or exports to countries were CSFs are required or recommended.
Development of trials for claims support and justification for advertising (efficacy) claims
Any specific claims you make require evidentiary support, so that your product works as intended. We help design protocols for trials that will support the unique claims you make to distinguish your product from its competitors. Increased consumer awareness has made it more important than ever that unique claims be backed by scientific data.