Current Good Manufacturing Practices (cGMP) Audits
With the implementation of cGMP regulations in the US and similar safety initiatives internationally, regulatory inspections have increased dramatically, making your business more susceptible to regulatory enforcement. Understanding the rules, regulations, responsibilities, and your liability is more important than ever before. We understand the difficulties and complexities many companies face when launching their supplements, or maintaining the place in the markets with changing laws and can help you navigate these challenging rules. Whether conducting a cGMP audit of your facility, helping draft master manufacturing or batch production records, drafting SOPs, or simply helping you understand how the law impacts you, your products, and your business, our team can help.
International Regulatory Experts Servicing Over 40 Countries
Finding and working with experts in each country can be especially difficult, time-consuming, and result in unnecessary costly mistakes. Rather than using a large law firm or an untried contact you have in the country, let our team of seasoned and proven experts guide you through the regulatory process so that your supplements can be in the marketplace without fear of litigation. We service over 40 countries and can provide services from market-entry regulatory strategy to product registration and advertising reviews.
Supplement Labeling | Dietary Supplement Advertising
We not only understand the laws and regulations of labels and advertising but also keep a close eye on current supplement litigation practices and cases to provide a realistic risk analysis for our clients. Our team has supported, and continues to support, start-ups to multi-billion dollar enterprises in gauging and managing dietary supplement regulatory risk, allowing our clients to be compliant and competitive. Whether you need help creating your supplement’s label, or reviewing a label, or reviewing your advertising for compliance—our team can help.
Supplement Regulatory Experts | Expert Witness
Our team of experts has a deep and diverse background of expertise and has provided support in a variety of far-reaching cases, including landmark cases such as POM v FTC, which was taken all the way to the US Supreme Court. Whether you need an expert witness, regulatory research, or general guidance in assessing the validity of your supplement’s claims, our team can assist.
FDA Regulatory Training for Your Team
Many companies are unsure of where to begin or how to instill a culture of dietary supplement regulatory compliance that meets the FDA’s expectations. Our experts can train your team, whether on-site or remotely, to help your team understand current 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 or supplement law, let us help you be better prepared to face the regulatory hurdles in your way.
FDA Inspections | FDA Warning Letters
The FDA will show up at your facility. Are you prepared? 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 FDA’s demands but also protecting you from over-regulation, which unfortunately does happen. 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.