U.S. Agent Representation
At KRTL Biotech, our U.S. Agent Representation services are designed to simplify your
engagement with the U.S. Food and Drug Administration (FDA) and ensure seamless regulatory
compliance. As your designated U.S. agent, we act as your trusted intermediary, facilitating
effective communication with the FDA, managing critical documentation, and ensuring
adherence to all federal requirements. With KRTL Biotech, international pharmaceutical
companies gain a reliable, knowledgeable partner to navigate U.S. regulations with confidence
and precision.
Core Offerings
KRTL Biotech delivers a full suite of U.S. Agent Representation services, ensuring your company meets all FDA requirements and remains compliant throughout the product lifecycle. From document submissions to inspections, we provide comprehensive support every step of the way.
FDA Liaison Services: Serving as the official point of contact with the FDA for all communication and inquiries.
Regulatory Document Management: Managing submissions, filings, and other essential regulatory documents on your behalf.
Emergency Contact Representation: Acting as your primary contact for any FDA-related emergencies, including recalls or adverse events.
Compliance Monitoring: Providing ongoing support to ensure adherence to FDA requirements and timelines.
Inspection Support: Assisting with FDA inspections, including preparation, communication, and follow-up.
Annual Registration Management: Overseeing establishment registration renewals and updates to maintain compliance.
Labeling Review & Compliance: Ensuring product labels meet all FDA guidelines, including content accuracy and format.
Adverse Event Reporting: Managing the submission of adverse event reports and other post-market obligations.
Regulatory Strategy Guidance: Offering tailored advice to align regulatory activities with your business objectives.
Real-Time Regulatory Updates: Keeping you informed of evolving FDA requirements and policy changes.
Why Choose KRTL Biotech?
Innovation-Driven Solutions
We excel at turning challenges into opportunities by integrating forward-thinking strategies and cutting-edge technologies to drive measurable results.
Scalable Partnerships
Our flexible collaboration models allow us to align with your goals, ensuring sustainable growth and long-term success.
Global Expertise
With a strong international presence, we bring market insights, strategic support, and a global network to help expand your business impact.
Commitment to Excellence
At every step, we prioritize quality, reliability, and transparency to create lasting partnerships that deliver value.
KRTL Biotech is more than a business partner—we are a catalyst for growth and innovation. By combining strategic vision with collaborative expertise, we empower businesses to achieve new levels of success.
Connect with us today to explore how we can work together to unlock opportunities, drive growth, and shape a sustainable future.