A Wholly Owned Subsidiary of KRTL Holding Group Inc (OTC: KRTL)
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.
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FDA Liaison Services: Serving as the official point of contact with the FDA for all communication and inquiries.
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Regulatory Document Management: Managing submissions, filings, and other essential regulatory documents on your behalf.
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Emergency Contact Representation: Acting as your primary contact for any FDA-related emergencies, including recalls or adverse events.
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Compliance Monitoring: Providing ongoing support to ensure adherence to FDA requirements and timelines.
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Inspection Support: Assisting with FDA inspections, including preparation, communication, and follow-up.
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Annual Registration Management: Overseeing establishment registration renewals and updates to maintain compliance.
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Labeling Review & Compliance: Ensuring product labels meet all FDA guidelines, including content accuracy and format.
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Adverse Event Reporting: Managing the submission of adverse event reports and other post-market obligations.
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Regulatory Strategy Guidance: Offering tailored advice to align regulatory activities with your business objectives.
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Real-Time Regulatory Updates: Keeping you informed of evolving FDA requirements and policy changes.
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Expert FDA Liaison & Communication
As your designated U.S. agent, KRTL Biotech serves as the official liaison between your company and the FDA, ensuring clear, timely, and accurate communication. Whether it’s responding to inquiries, submitting documentation, or addressing compliance issues, we represent your interests with professionalism and precision to avoid delays and miscommunications.
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Comprehensive Compliance Management
KRTL Biotech takes the stress out of FDA compliance by managing essential filings, submissions, and annual registration updates. Our expert team also supports labeling compliance and adverse event reporting, ensuring all requirements are met promptly and accurately. From pre-market activities to post-market obligations, we monitor and guide you through every regulatory step
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Proactive Inspection & Emergency Support
KRTL Biotech's is your trusted partner during FDA inspections and emergencies. We prepare your operations for audits, provide on-the-ground support during inspections, and handle post-inspection follow-ups. In urgent situations, such as recalls or adverse events, we act swiftly to manage communication with the FDA and ensure a compliant response that minimizes risks to your business.
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.