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.
¿Por qué elegir KRTL Biotech?
Soluciones basadas en la innovación
Nos destacamos en convertir los desafíos en oportunidades mediante la integración de estrategias vanguardistas y tecnologías de vanguardia para impulsar resultados mensurables.
Asociaciones escalables
Nuestros modelos de colaboración flexibles nos permiten alinearnos con sus objetivos, garantizando un crecimiento sostenible y un éxito a largo plazo.
Experiencia global
Con una fuerte presencia internacional, aportamos conocimiento del mercado, apoyo estratégico y una red global para ayudarle a expandir el impacto de su negocio.
Compromiso con la excelencia
En cada paso, priorizamos la calidad, la confiabilidad y la transparencia para crear asociaciones duraderas que generen valor.
KRTL Biotech es más que un socio comercial: somos un catalizador para el crecimiento y la innovación. Al combinar la visión estratégica con la experiencia colaborativa, empoderamos a las empresas para que alcancen nuevos niveles de éxito.
Conéctese con nosotros hoy para explorar cómo podemos trabajar juntos para desbloquear oportunidades, impulsar el crecimiento y dar forma a un futuro sostenible.