Market Entry

At MyFDALawyers.com, PC, our FDA lawyers have the knowledge, skills, and legal expertise to help businesses navigate entry into the U.S. market. Taking a proactive approach helps minimize risk while preparing your product in the most efficient and cost-effective way. If you have any specific questions or concerns about market entry for foods, dietary supplements, animal products, cosmetics, medical devices, drugs, or other consumer products, we are here to help. Contact our attorneys today about bringing your product to the U.S. market for a confidential initial consultation.

What is Market Entry and Why Does it Matter?

Market entry refers to the legal and regulatory process by which a product becomes eligible for lawful commercial distribution in the United States. For FDA-regulated commodities (food, dietary supplements, medical devices, OTC drugs, homeopathic drugs, etc), market entry requires premarket compliance with several requirements, often including facility registration, product listing, ingredients and / or formulation, labeling, manufacturing safety. Proactive compliance is a must. The failure to meet these requirements can result in detention, refusal of admission, warning letters, or enforcement action. A compliant market entry strategy not only minimizes legal risk but also accelerates time-to-market.

We Provide Proactive Support to Facilitate Market Entry

At MyFDALawyers.com, we specialize in FDA-related business representation. Our firm can help you with all matters related to market entry. Our FDA market entry lawyers are prepared to help your company with:

• Product Classification: Product classification is one of the key areas of market entry. Understanding how the FDA classifies your product is the foundation of lawful market entry. We assist clients in determining whether their product is a food, dietary supplement, cosmetic, drug, medical device, or a type of combination product. This directly impacts the applicable regulatory framework.
• Labeling Review: Labeling is one of the most common areas where companies run into FDA trouble. We conduct detailed reviews of product labels, packaging, websites, social media, and marketing materials to ensure that all required elements are included and that no unauthorized claims are made.
• Regulatory Compliance: We assist with facility registration, product listing, good manufacturing practices (GMP), and compliance with applicable monographs or premarket approval pathways. Whether your product is subject to the Food Safety Modernization Act (FSMA) or must meet device listing requirements, our lawyers ensure full compliance
• Contracts: We draft, review, and negotiate contracts that are essential to FDA-compliant market entry. This includes manufacturing agreements, private label contracts, purchase and sale agreements, indemnification clauses, and supplier verification documentation. Every contract must account for regulatory obligations, especially when responsibility is shared across the supply web of FDA regulated entities.

How Our FDA Lawyers Can Help With Market Entry

Our firm has extensive experience helping businesses nationwide get their FDA-regulated products on the market. Delays (or denials) can cost your company a lot of money. Attorneys Rick D. Quinn and Bill Senior have worked closely with hundreds of FDA-regulated companies across a broad range of industries and product types. We are proactive. Our FDA lawyers will:

• Listen to your story and understand your situation.
• Help you gather and prepare all support documents, records, and evidence.
• Handle FDA regulatory and compliance.
• Develop a comprehensive market entry strategy.