Tailored Solutions

Transcending Expectations, Fostering Trust

Unparalleled Service and Product Quality • Dedicated to Customer Satisfaction

UBI Pharma Inc., specialize in protein and small molecule drugs, is dedicated to empowering our clients to achieve their pharmaceutical goals. Beyond offering CMO services, we go the extra mile by providing one-stop CDMO services to fulfill the entire product lifecycle.

From laboratory inception to regulatory approval, we offer comprehensive support encompassing product formulation and process development, analytical method development and validation, pilot and submission batch production, stability testing, regulatory document preparation, and response to review comments. Our unwavering commitment to quality, coupled with our exceptional research and analytical capabilities, optimized project timeline management, extensive international submission experience, and rigorous quality standards, ensures that our clients' products transition seamlessly from concept to commercialization, ultimately achieving successful market entry.

At UBI Pharma Inc., we pride ourselves on providing exceptional, reliable, and high-quality CMO/CDMO services, making us your ideal partner throughout the pharmaceutical development process.

Our service portfolio

• Formulation and Process Development Services

UBI Pharma Inc. offers comprehensive development services for both protein and generic drugs, including research related to Quality by Design (QbD), early-stage formulation research, and formal formulation development. These services are designed to assist clients in achieving their clinical objectives while integrating Critical Process Parameters (CPPs) to enhance process control and product quality.

From small-scale pilot batches and clinical batch production to the critical scale-up and submission batch manufacturing phases, UBI Pharma Inc. provides specialized support at every stage of product development, ensuring optimization of critical processes to meet our clients' expectations.

• Drug Manufacturing Services

Our core expertise lies in the production of sterile injectable products, and we provide adaptable solutions to tackle complex processes. Whether it involves small molecule or protein drugs, liquid or lyophilized formulations, or spans across clinical or commercial projects, our commitment to excellence remains unwavering. Backed by a team of over 200 highly skilled professionals, cutting-edge production facilities certified by PIC/S GMP, and consistent recognition from international regulatory agencies, including regular inspections by the USFDA and Japan's PMDA, we consistently deliver product quality that sets industry benchmarks. We take pride in maintaining an impeccable track record spanning more than two decades without a single product recall. Furthermore, we continually enhance our pharmaceutical infrastructure and refine our processes to meet the evolving demands of the industry while surpassing the expectations of our valued customers.

• Analytical Services

UBI Pharma Inc. offers comprehensive analytical services to underpin drug development and manufacturing processes, guaranteeing the creation of regulatory-compliant documentation.

Our analytical suite includes raw material testing, product release testing, stability assessments, and research services for evaluating product shelf-life and potency across diverse conditions. Whether starting from scratch or streamlining technology transfer, our proficient team is unwaveringly committed to securing dependable and uniform test outcomes, ensuring seamless compliance with international regulatory authorities throughout the product development journey.

• Clinical and Regulatory Services

At UBI Pharma Inc., our accomplished team also provides expert clinical and regulatory services, offering consultation and tailored solutions to guide clients through all kinds of regulatory challenges for global market entry. Our comprehensive offerings encompass non-clinical and clinical study design and execution, CTD document preparation, pre- and post-approval submissions, and expert consulting services.

Drawing from extensive international experience in regulatory submissions, covering diverse areas including small molecule and protein drugs, New Chemical Entities (NCEs), New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs), we deliver adaptable and customized clinical and regulatory support which meet clients' needs and align with their product development phases. Align with our proactive engagement with regulatory agencies, we effectively guide our clients through all these regulatory requirements, ultimately bringing their pharmaceuticals to market successfully.

Outstanding Achievements

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