ABOUT US

STRATEGIC AND TACTICAL REGULATORY CONSULTING SERVICES FOR THE GLOBAL AND FDA-REGULATED INDUSTRY

Headquartered in the San Francisco Bay Area and founded in 2009 as a regulatory affairs consultancy, Universal Regulatory Inc is focused on providing comprehensive consulting services in Regulatory Affairs by combining strong technical expertise in pharmaceutical development with knowledge of global regulatory environments. Our Principal and consulting experts have a 15+ years pharmaceutical industry experience and a majority hold advanced degrees.

Regulatory Affairs with an Emphasis on Regulatory Sciences

Over the past decade Universal has built a successful track record, assisting clients in 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.

Niamh Kinsella, Ph. D.

VP, Early Stage Development
NDA Group (United Kingdom)

Over the years, the team at Universal Regulatory Inc. has supported NDA with our clients’ US projects and this support has covered all stages of development and has included both regulatory and CMC support. In addition, Universal Regulatory has supported our clients by providing US Agent support which has enabled our clients to maintain their programmes in the US.

Vitally important to our projects was their US FDA expertise and knowledge, which on top of their ability to provide insight and deliver on time, contributed to successful submissions on behalf of our clients in the US.

Our
Services

Regulatory Strategy Consulting

Regulatory Submissions Preparation and Planning

Health Authority Meetings

Interim Support- Regulatory Personnel Transitions

US Agent Services

Regulatory Oversight of Worldwide Clinical Trials

Regulatory Operations Support

Deepa Deshpande, PhD, RAC

Dr. Deshpande is Founder and President of Universal Regulatory Inc with over 22 years’ experience in pharmaceutical industry, with multi-functional expertise in Regulatory Affairs (clinical, nonclinical and CMC). Primary focus is to help clients develop and execute regulatory strategy through product approval.

Dr. Deshpande 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.

Strong technical background in pharmaceutical development for small molecule, biologics, and combination products development. Experienced in negotiating with US and international regulatory authorities. Accomplishments include multiple 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, twice elected by membership of pharmaceutical organization (AAPS) to a leadership role, served as chairperson and speaker at several workshops, symposia on topics related to 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.

Elliot P Goldstein, MD

Chief Operating Officer/Chief medical Officer
Maxygen, Inc

Dr. Deepa Deshpande has served as chief regulatory consultant for Maxygen, Inc. She stepped into this role upon the unexpected departure of our director of regulatory affairs. Deepa quickly and efficiently came up to speed on our most advanced biological product. She was overall responsible for the regulatory strategy and document submission to the FDA on this program, leading to a very positive written response from the regulators.

Dr. Deepa has excelled in multiple domains, including her technical knowledge of the FDA and other regulatory authorities, her ability to work effectively at both the strategic and operational levels, and her flexible and open attitude which has greatly facilitated her rapid integration into Maxygen project teams.

It has been a real pleasure working with Deepa and I am delighted to recommend her services with no reservations.