fda label reviews and consulting for over-the-counter drugs (otc drugs)

Over the Counter Drugs

CGMP OTC Drugs | OTC Drugs Facility 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.

International Over-the-Counter Drugs Regulatory Compliance

Finding and working with experts in each country can be difficult, time-consuming, and result in costly mistakes that are completely unnecessary. Rather than use a large law firm with saturated fees or an unproven contact you have in the country, let our team of seasoned, qualified experts guide you through the nonprescription drug regulatory process. We service over 40 countries in all of the OTC drug compliance processes and can provide services from market-entry regulatory strategy to product registration and advertising reviews.

OTC Drug Product Labeling 21 CFR 201 | OTC Drug Product Advertising and Compliance | Formula Reviews

We not only understand the OTC drug laws and regulations of over-the-counter 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 startup companies who have just begun marketing their formulas, to well-established, multi-billion dollar enterprises in gauging and managing OTC drug regulatory risk, allowing our clients to be compliant yet competitive. Whether you need help creating or reviewing a label for you over-the-counter product, or reviewing your advertising for compliance, our team can help.

Litigation Consulting | Formula Review Experts | Expert Witness

Our team of experts has a diverse background of expertise and has provided support in a variety of important cases, including landmark cases such as POM v FTC, which reached 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 you through the process.

FDA Inspection Training | Nonprescription Drug 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, both on-site or remotely, to help your team have a better understanding of how to understand FDA regulations and regulatory risk for your OTC products. Whether you need a basic understanding of the laws and regulations of a new nonprescription medicine 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 / FDA 483 Warning Letters

The FDA showed up at your facility, you received a warning letter or form 483, or need to conduct a product recall—what happens now? 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. Over-regulation happens, but with proper representation, you can avoid it. Many companies do no understand their rights or understand the FDA’s limitations. Let us help you navigate this difficult situation to protect your company and help bring any concerns to a quick and thorough conclusion.

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