UBI Pharma Inc. stands at the forefront of the pharmaceutical industry with our seasoned Regulatory Affairs team, proficient in both domestic and international regulations, offering a comprehensive end-to-end regulatory service to customers. Our mission is to facilitate our clients‘ attainment of pharmaceutical certifications across diverse countries, enabling the global expansion of their product sales. Together, we serve as an indomitable force in achieving the dual objectives of advancing new drug development and ensuring regulatory compliance. With us as your steadfast partner, success in new drug development and regulatory compliance is assured.
Our Services Encompass：
Pre-Clinical Trials
Clinical Trials
New Drug Certification
Generic Drug Certification
Drug Development Process
What We Provide
Pre-Clinical Trials
We provide assessments for non-clinical trial design and product development strategy, including animal PK/TK evaluation and safety pharmacology, animal general toxicity (repeated dose for 14/28/90/180 days) and non-clinical trial execution.
We can also draft non-clinical documents for new drugs on behalf of clients, ensuring that the content and format comply with international regulations such as ICH and CTD/eCTD. Additionally, we assist clients in addressing deficiency requirements from health authorities in various countries during registration inspections.
Clinical Trials
We provide a comprehensive array of services, including consultation on drug BA/BE, PK/PD, Phase I through Phase IV clinical trial design. We also offer assistance with government agency and hospital applications/submissions, clinical trial project management, hospital management, GCP inspection, and resolution of various clinical trial-related issues.
We can also prepare clinical documents for new drugs on behalf of our clients, ensuring that the content and format comply with international regulations like ICH and CTD/Ectd. Furthermore, we assist clients in addressing deficiency requirements from health authorities in different countries during registration inspections.
Registration
New Drugs Our adept team can meticulously craft New Drug Clinical Trial and Registration Phase CTD documents on your behalf, ensuring seamless alignment with international regulations, including ICH and CTD/eCTD. We provide unwavering support in addressing any deficiencies identified by health authorities during registration inspections. Leveraging our extensive experience in managing multiple new drug clinical trial applications and biosimilar drug registrations, we streamline the new drug development process, expediting your path to market.
Generic Drugs We excel in composing Chemistry, Manufacturing, and Controls (CMC) submission documents for generic drugs, strictly adhering to the content and format stipulations of both Taiwanese and international regulations, such as ICH and CTD/eCTD. Our expertise extends to aiding clients in resolving any deficiency requirements posed by health authorities during registration assessments. UBI Pharma Inc. boasts a remarkable track record, having secured approvals for more than five Abbreviated New Drug Applications (ANDAs) in the United States, as well as two ASEAN generic drug approvals. Our achievements encompass the approval of complex products that integrate drugs and medical devices, along with diverse drug registration changes/variations.
Choose UBI Pharma Inc. for unparalleled regulatory compliance solutions that pave your path to pharmaceutical success on a global scale.
