Food & Beverages
FSMA Compliance Audits / cGMP Audits
With the implementation of the Food Safety Modernization Act (FSMA) in the US, and similar food safety initiatives internationally, understanding the rules, regulations, responsibilities and your liability is more important than ever. Our team was heavily involved with many industry associations during the development and implementation of FSMA. We understand the difficulties and complexities many companies face and can help you navigate these challenging rules. Whether conducting an FSMA audit of your facility, helping draft a food safety plan, drafting SOPs, or simply helping you understand how the law impacts you and your business, our team can help.
International Regulatory Experts
Finding and working with experts in each country can be difficult, time-consuming, and result in costly mistakes. Rather than using a large law firm or the cousin of so-and-so from a contact you have in the country, let our team of seasoned experts guide you through the regulatory process, unique to your country’s specific laws. We service over 40 countries and provide a range of services from market-entry regulatory strategy to product registration and even advertising reviews.
Food Labeling and Advertising | Beverage Labeling and Advertising
We not only understand the laws and regulations of labels and advertising, but we also keep a close eye on litigation practices and cases 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. This allows our clients to be compliant and competitive. Whether you need help creating or reviewing a label, or reviewing your advertising for FDA compliance, our team can help.
Regulatory Process Experts
Our team of qualified experts has a diverse background of expertise and has provided support in a variety of cases, including benchmark cases such as POM v FTC, which soared all the way to the US Supreme Court. Whether you need an expert witness, regulatory research, or general guidance in assessing the validity of claims, our team can assist.
FDA Compliance Training for Your Team
Many companies are unsure of where to begin or even how to instill a culture of regulatory compliance that is streamlined and effective. Our experts can train your team, both on-site and remotely, to help you and your team have a better understanding of how to understand regulations and regulatory risk. Whether you need a basic understanding of the FDA’s 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.
USDA and FDA Inspections / FDA Warning Letters
What happens when the FDA shows up at your facility? Or maybe 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, USDA but also protecting you from over-regulation. Many companies don’t understand their rights or even 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.