Universal Regulatory
Universal Regulatory Inc, founded in 2009 and headquartered in the San Francisco Bay Area, specializes in comprehensive regulatory consulting services for the global and FDA-regulated industry. With a team of experts with over 15 years of pharmaceutical industry experience, they focus on regulatory affairs, supporting clients in US, European Union, and Asia to achieve regulatory milestones across product quality, nonclinical, clinical development, and compliance. Their mission is to provide strategic and tactical regulatory support, leveraging strong technical expertise and knowledge of global regulatory environments, to facilitate drug development and approval processes.
Industries
Nr. of Employees
small (1-50)
Universal Regulatory
Fremont, California, United States, North America
Services
Advisory services to develop regulatory strategy and product development plans across development stages and therapeutic areas.
Preparation and tactical support for regulatory filings (IND, NDA, BLA, DMF, CTA, MAA, NADA) and related amendments and reports.
End‑to‑end support for preparing and conducting regulatory meetings with health authorities, including briefing documents and meeting strategy.
Interim regulatory leadership and staff augmentation to cover transitions and provide continuity of regulatory operations.
Representation of ex‑US sponsors as US agent and liaison with US regulatory authorities.
Regulatory review and oversight for multinational clinical trials, including protocol review and responses to authorities and ethics committees.
Advisory services to develop regulatory strategy and product development plans across development stages and therapeutic areas.
Preparation and tactical support for regulatory filings (IND, NDA, BLA, DMF, CTA, MAA, NADA) and related amendments and reports.
End‑to‑end support for preparing and conducting regulatory meetings with health authorities, including briefing documents and meeting strategy.
Interim regulatory leadership and staff augmentation to cover transitions and provide continuity of regulatory operations.
Representation of ex‑US sponsors as US agent and liaison with US regulatory authorities.
Regulatory review and oversight for multinational clinical trials, including protocol review and responses to authorities and ethics committees.
Expertise Areas
- Regulatory strategy and consulting
- Regulatory submissions and dossier preparation
- Health authority meeting preparation and support
- Clinical trial regulatory oversight
Key Technologies
- eCTD/CTD electronic submissions
- Regulatory dossier authoring
- Electronic publishing workflows
- Clinical protocol regulatory review
News & Updates
Recent Projects
Examples of completed projects including regulatory leadership, strategic consulting, FDA interactions, IND filings, and clinical trial support.
Recent Projects
Examples of completed projects including regulatory leadership, strategic consulting, FDA interactions, IND filings, and clinical trial support.