Welcome to Regulatory Doctor

U.S. Agent services are essential for foreign companies seeking to market their medical devices, pharmaceuticals, biologics, or other regulated products in the United States. These services ensure compliance with FDA regulations by providing a reliable communication channel between the foreign company and the FDA.

Key Responsibilities of a U.S. Agent

Primary FDA Contact

• Serve as the official point of contact for all FDA communications, including registration, inspections, and compliance issues.

Facilitate FDA Communication

• Assist in responding promptly to FDA inquiries, document requests, and notifications.
• Ensure all correspondence between the FDA and the foreign establishment is managed efficiently.

Support During Inspections

• Help coordinate FDA inspections and assist with follow-up actions.
• Provide guidance to address and resolve FDA concerns during or after inspections.

Regulatory Guidance

• Advise on FDA regulatory requirements and assist in preparing and submitting regulatory documents such as 510(k), PMA, NDA, BLA, or DMFs.
• Provide ongoing updates on FDA policy changes that may impact the company’s operations or products.

Emergency Notifications

• Act as a point of contact in emergencies, such as recalls or urgent safety-related concerns requiring FDA action.

Why U.S. Agent Services Are Critical

Regulatory Requirement: Foreign companies must designate a U.S. Agent to comply with FDA regulations for facility registration and product listing.

Efficient Communication: Facilitates timely communication and minimizes potential regulatory delays.

Expert Support: Provides valuable expertise to navigate FDA requirements and ensure smooth operations in the U.S. market.

Who Needs U.S. Agent Services?

Manufacturers of medical devices, drugs, biologics, and dietary supplements.

Facilities involved in producing, processing, or distributing FDA-regulated products.

Contract research organizations (CROs) and laboratories conducting FDA-regulated studies.

Benefits of Choosing Regulatory Doctor for U.S. Agent Services

Expert Team: Comprehensive knowledge of FDA regulations across diverse industries.

Proactive Approach: Continuous monitoring of regulatory requirements to keep your business ahead of compliance challenges.

Personalized Support: Tailored solutions to meet your unique business needs and ensure seamless FDA interactions.

With our U.S. Agent services, foreign companies can confidently navigate the U.S. regulatory environment and achieve successful market entry and operations.

Our Risk Management Consulting services help firms identify and mitigate business risks. We work with you to develop a risk management plan that fits your business needs and helps you protect your business from potential risks and threats.