Healthcare & Medical Industry
Redefining Borders with Expert Perspective.
Healthcare & Medical Industry
In the healthcare and medical industry, compliance with international trade regulations, import/export restrictions, and sanitary requirements is essential to ensure the smooth and legal operation of businesses involved in medical devices, pharmaceuticals, biotechnology, and healthcare services
At Lexnova USA, we provide specialized legal solutions to help healthcare companies navigate the complexities of cross-border trade, regulatory compliance, and supply chain management while ensuring their products and services meet all industry-specific standards.
Import & Export Compliance for Medical Devices and Pharmaceuticals
We assist in obtaining permits, certifications, and regulatory approvals for the import and export of medical equipment, pharmaceuticals, and healthcare products, ensuring compliance with FDA, and other international health agencies
HIPAA & Data Protection Compliance
For companies handling electronic health records (EHR), telemedicine services, or patient data, we ensure full compliance with HIPAA regulations, protecting sensitive medical information and avoiding legal liabilities.
Medical Imports & Tariff Classification
We guide companies in HTS (Harmonized Tariff Schedule) classification, customs clearance, and duty optimization, ensuring cost-effective and compliant import/export operations under programs like Section 321, USMCA, and duty-free exemptions for medical equipment.
Areas of Expertise
Regulatory Affairs & Good Manufacturing Practices (GMP
We provide legal support to ensure compliance with cGMP (Current Good Manufacturing Practices), ISO 13485 certification, and other quality standards required for medical products distributed in the U.S. and international markets.
Legal Support for Clinical Trials & Biotechnology
For biotech and pharmaceutical companies, we assist with clinical trial agreements, licensing, and regulatory filings, ensuring full adherence to FDA’s Investigational New Drug (IND) regulations and Institutional Review Board (IRB) requirements.
Legal Defense in FDA Audits & Customs Investigations
In case of FDA audits, import holds, or customs penalties, we provide legal representation and compliance strategies to help your company resolve disputes with U.S. regulatory agencies and avoid product seizures or fines.
Nearshoring & Expansion Strategies for Medical Companies
We assist foreign medical manufacturers looking to establish production, assembly, or R&D facilities in the U.S. and Mexico, ensuring compliance with local regulations and optimizing investment incentives.
Lexnova USA
At Lexnova USA, we understand the challenges of the U.S. healthcare industry and provide expert legal guidance to help your company stay compliant, reduce risks, and operate efficiently in the international market.
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