Over the Counter Drugs
cGMP / Audits
Whether you manufacture OTC drugs or utilize contract manufacturers to produce your product, our experts can help meet 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 OTC cGMP 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.
Labeling / Advertising
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.
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 all the way to the US Supreme Court. Whether you need an expert witness, regulatory research, or general guidance in assessing validity of claims, our team can assist.
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.
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.