KRTL Biotech Services
KRTL Biotech Inc. offers a dual approach to supporting the pharmaceutical industry. As both a solutions provider and a pharmaceutical company, we deliver comprehensive services to help companies navigate regulatory complexities, streamline operations, and bring therapies to market efficiently. Simultaneously, we offer a portfolio of Active Pharmaceutical Ingredients (APIs) and finished products available for white labeling, empowering our partners to expand their offerings with high-quality, ready-to-market solutions.
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Our regulatory compliance and product registration expertise ensures companies meet FDA requirements seamlessly, while our global import/export logistics solutions provide secure, on-time delivery of products. As a U.S. agent, we handle critical FDA communications, allowing clients to focus on innovation while we manage compliance. Rigorous quality assurance and control processes underpin every step, guaranteeing safety and efficacy.
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Additionally, we provide manufacturing and labeling solutions tailored to meet diverse regulatory and market needs. For products in development, our clinical trial and post-market support services ensure performance evaluation and ongoing compliance. Beyond these services, KRTL Biotech’s own APIs and finished products are crafted with precision and innovation, offering a scalable and flexible solution for businesses seeking to white label and expand their portfolio.
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At KRTL Biotech, we combine industry expertise with a commitment to innovation, offering integrated services and products that meet the demands of an evolving pharmaceutical landscape. Whether partnering to bring your product to market or leveraging our APIs and finished products, we provide the tools to succeed in today’s competitive environment.
What We
Offer
01
Regulatory Compliance & Registration
We simplify the complexities of U.S. regulatory requirements by managing product registration, FDA compliance, and certification processes. Our team offers detailed guidance at every stage, from initial documentation preparation to final approval, ensuring your products meet the latest industry standards.
By leveraging our thorough understanding of regulations and agency expectations, we help you avoid costly delays and streamline your market launch.
02
Global Import/Export & Logistics
With extensive experience in international operations, we manage the entire import/export process to guarantee the smooth, timely, and compliant delivery of pharmaceutical products. From handling customs documentation, coordinating with regulatory authorities, to navigating tariff structures and logistics challenges,
we ensure efficient global distribution. Our tailored solutions address country-specific regulations and mitigate risks to optimize your supply chain.
03
U.S. Agent Representation
As your trusted U.S. agent, we act as an official liaison with the FDA, ensuring your business complies with all local regulatory obligations and communication protocols. Our team provides expert representation, timely submission of required documents, and seamless coordination during inspections or audits.
With our guidance, you maintain confidence and transparency when engaging with U.S. regulatory bodies.
04
Quality Assurance & Quality Control (QA/QC)
We are dedicated to upholding the highest global standards for product safety, consistency, and efficacy. Our QA/QC processes include comprehensive audits, rigorous testing, and continuous monitoring to ensure your products meet or exceed all required compliance benchmarks.
By implementing advanced methodologies and quality systems, we help mitigate risks and deliver reliable results that foster customer trust.
05
Manufacturing & Labeling Solutions
Our manufacturing services connect you with trusted, FDA-compliant facilities that align with your specifications and quality standards. Whether it’s small-batch production or large-scale manufacturing, we ensure efficiency and quality at every stage. Additionally, we provide comprehensive labeling solutions that
comply with U.S. regulations, including accurate ingredient listings, safety guidelines, and compliant design.
06
Clinical Trial & Post-Market Support
From early-phase clinical trials to post-market activities, we provide critical support to bring new therapies to market and monitor their ongoing performance. Our services include trial design, data collection, safety monitoring, and regulatory reporting, ensuring strict adherence to compliance standards.
Post-launch, we offer robust surveillance systems to monitor safety, performance, and market feedback, enabling continuous improvement and compliance.
07
Research & Development (R&D)
Our R&D services reflect our commitment to innovation and product advancement. We collaborate with pharmaceutical companies to support new drug development, optimize production processes, and explore emerging opportunities. With a focus on science-driven solutions,
we help accelerate discovery and deliver efficient, scalable results that meet the demands of today’s dynamic market.
08
Supply Chain & Logistics Management
We provide end-to-end supply chain and logistics management to ensure seamless operations at every stage. From sourcing raw materials to distribution of final products, our solutions optimize efficiency, reduce costs, and enhance reliability. Our expertise in planning, procurement, warehousing, and transportation
ensures that your supply chain is responsive, agile, and aligned with market demands.
