Regulatory Affairs Consulting
Strategic and Tactical Regulatory Consulting Services for the Global and FDA-Regulated Industry
Headquartered in the San Francisco Bay Area and founded in 2009, Universal Regulatory Inc provides comprehensive consulting services combining strong technical expertise in pharmaceutical development with knowledge of global regulatory environments.
About Us
Regulatory Affairs with an Emphasis on Regulatory Sciences
Over the past decade Universal has built a successful track record, assisting clients in the US, European Union and Asia accomplish regulatory milestones encompassing product quality, nonclinical, clinical development, regulatory compliance and health authority negotiations. We specialize in working with small to mid-size biotechnology and pharmaceutical companies with seamless integration into project teams.
Contact us to discuss how we can support your drug development program. →Expertise
Our Services
Regulatory Strategy Consulting
Strategic guidance navigating FDA and global regulatory pathways
Regulatory Submissions Preparation and Planning
End-to-end support for IND, NDA, BLA, MAA filings
Learn More →Health Authority Negotiations
Expert representation and communication with US and EU health authorities
Learn More →CMC Regulatory Support
Chemistry, manufacturing, and controls regulatory expertise
Learn More →Client Testimonials
What Our Clients Say
"Over the years, the team at Universal Regulatory Inc. has supported NDA with our clients' US projects… Vitally important to our projects was their US FDA expertise and knowledge, which contributed to successful submissions on behalf of our clients in the US."
Niamh Kinsella, Ph.D.
VP Early Stage Development, NDA Group (United Kingdom)
Leadership
Universal Team
Deepa Deshpande, PhD, RAC
Founder and President, Universal Regulatory Inc.
Dr. Deshpande has over 22 years' experience in the pharmaceutical industry, with multifunctional expertise in Regulatory Affairs (clinical, nonclinical and CMC). Primary focus is to help clients develop and execute regulatory strategy through product approval. She has served as regulatory consultant and advisor for over 60 pharmaceutical and biotechnology companies, including serving as Interim Vice-President/Head Regulatory Affairs. She holds a Masters and PhD in Pharmaceutical Sciences and is RAC certified.
Key Accomplishments
- ▸Successful IND, CTA, NDA, NADA filings
- ▸NDA/BLA/MAA preparation, review and planning
- ▸Track record of successful interactions with US and EU Health Agencies
- ▸Recognized contributor in pharmaceutical community
- ▸Elected by membership of pharmaceutical organization (AAPS) to a leadership role
- ▸Served as chairperson and speaker at several workshops and symposia on regulatory affairs and product development
Universal Regulatory Consulting Group, Affiliates
Universal's Consulting group includes experts with a wide-range of technical expertise and regulatory affairs experience, including regulatory strategy and compliance, CMC-regulatory, regulatory operations, project management, clinical operations, and electronic publishing. We are ready to mobilize a team of experts to meet the specific needs of your project.
Contact Us