Cosmetics / Skin Care
Cosmetic cGMP / Audits
Whether you manufacture cosmetics or utilize contract manufacturers to produce your product, our experts can help meet FDA, regulatory and industry standards. We are able to conduct on-site or remote (desk-top) audits, review/draft standard operating procedures, review/draft product specifications, conduct cGMP training, conduct due diligence in transactions and mergers, and otherwise assist in all aspects of cosmetic cGMP compliance. Our cosmetic chemists can help with process validation and formulation scaleup to ensure your products can be produced successfully and to achieve your customer experience goals.
International Regulatory Compliance
Finding and working with experts in each country can be difficult, time-consuming, and result in costly mistakes. Rather than use a large law firm or the cousin of a contact you have in the country, let our team of seasoned experts guide you through the regulatory process. We service over 40 countries and can provide services from market-entry regulatory strategy to product registration and advertising reviews. We conduct formula reviews, label reviews, advertising reviews, and product registration or notification. Our firm can assemble product information files, can act as a responsible party, and can arrange for local addresses for our clients to use, where required by law.
Cosmetic and Skincare Product Labeling / Advertising Reviews and Compliance
We not only understand the laws and regulations of labels and advertising but also keep a close eye on litigation practices to provide a realistic risk analysis for our clients. Our team has supported companies from start-ups to multi-billion dollar enterprises in gauging and managing regulatory risk, allowing our clients to be compliant but competitive. Whether you need help creating or reviewing a label, or reviewing your advertising for compliance, our team can help.
Cosmetic Product Law Experts | Expert Witness
Our team of experts has a diverse background of expertise and has provided support in a variety of cases, including landmark cases such as POM v FTC, which was taken to the US Supreme Court. Whether you need an expert witness, regulatory research, or general guidance in assessing the validity of skincare claims, our team can assist.
FDA Compliance Training
Many companies are unsure of where to begin or how to instill a culture of regulatory compliance. Our experts can train your team, whether on-site or remotely, to help your team have a better understanding of how to understand regulations and regulatory risk. Whether you need a basic understanding of the laws and regulations of a new market you wish to enter, or your regulatory team needs in-depth training on a particular topic, let us help you be better prepared to face the regulatory hurdles in your way. If you are a cosmetic manufacturer, we provide in-depth cGMP and regulatory compliance training.
FDA Inspections / Warning Letters
The FDA showed up at your facility, you received a warning letter or form 483, or need to conduct a recall – now what? Our team can represent your company as you interact with the FDA, ensuring you meet the demands of the FDA but also protecting you from over-regulation. Many companies don’t understand their rights or the FDA’s limitations, so let us help you navigate this difficult situation to protect your company and help bring any concerns to a quick and thorough conclusion. We can oversee product recall or other FDA mandates to help get your business back on track quickly.