SERVICES

What We Do

Comprehensive Regulatory Expertise across the Therapeutic and Drug Development Spectrum.
Our senior regulatory professionals hold advanced academic, scientific credentials and are knowledgeable in early- and late-stage drug development across many therapeutic areas, including, but not limited to oncology (including immune-oncology and novel molecular targets), cardiovascular, metabolic, respiratory, infectious diseases, neuroscience, and inflammatory and immunological disease.
Knowledge Base Working With Diverse Technology Platforms.

Our consultants have broad experience working across various novel and established technology platforms including:

Combination products (drug-device)
Biosimilar
Orally Inhaled and Nasal Drug Products (OINDPs)
Controlled Release formulations (including liposome based systems)
Product types (small molecules, recombinant proteins, oligonucleotides, cell and gene therapy)

Mehdi Paborji

Senior Biopharma Executive

It’s a pleasure to endorse Universal Regulatory for their regulatory affairs consulting services. I had the pleasure of working with Universal under the leadership of Dr. Deepa Deshpande for over 2-3 years at Biotie Therapies. She has a broad and deep expertise in regulatory and experience working effectively with FDA and other regulatory authorities. We were lucky to find her in a consulting capacity at a critical time of starting phase 3 trials of our lead candidate where the head of our regulatory function retired. Her commitment to excellence and managing our regulatory requirements for the lead program as well as other programs all the way to the finish line were quite invaluable. In a short period of time, she effectively owned full responsibilities of regulatory function, overcome the challenges, and made significant contributions to all programs. She is extremely pleasant, approachable, knowledgeable, punctual, and takes her responsibilities very seriously.

Service Areas

Regulatory Strategy Consulting

Universal can assist clients in addressing regulatory affairs requirements—including providing leadership in developing a regulatory strategy and product development plan from pre-IND stage through approval, strategic advice on regulatory filings, precedence analysis, evaluation and resolution of complex scientific and regulatory issues.
We provide regulatory strategies, based on your corporate objectives, for new therapeutics and combination products, including assessment of applicability of unique programs, FDA approval pathways (505(b)(2), biosimilars, accelerated approval subpart E/H) and lifecycle management of marketed pharmaceuticals and biologics.
We specialize in working with start-ups, small to mid-side biotechnology companies, in providing guidance for “Pre-IND through First-in-Human” stage of development.

Regulatory Submissions Preparation and Planning

Our team will guide you through the strategic and tactical aspects of regulatory submissions including:

IND (US), Drug Master File (DMF), New Drug Application (NDA), Biologics License Application (BLA)
Information amendments (Nonclinical, CMC, Clinical)
Briefing documents to support meetings with US FDA and EU Scientific Advice
Annual Report
Development Safety Update Reports (DSUR)
Orphan drug designation
Fast track designation
Breakthrough designation (preliminary and full request)
Special Protocol assessments

Health Authority Meetings

Successful health authority meetings can significantly impact progress and program outcomes. Our expert consultants can guide though through the various steps of health authority meetings including Type A, Type B (pre-IND, End-of-Phase, pre-NDA, pre-BLA), Type C, Biosimilar Biological Product Development meetings and European Union Scientific Advice. We will guide you through the process of selection of discussion topics, preparation of regulatory submissions, team preparation, and liaising with health authorities as needed.

Interim Support- Regulatory Personnel Transitions

Our team has a successful track record with assisting clients with seamless transitions to manage transitions in regulatory affairs personnel.

US Agent Services

We have and continue to represent ex-US clients from Europe through Asia as US Agent, including serving as liaison with U.S. Food and Drug Administration.

Regulatory Oversight of Worldwide Clinical Trials

Our team is experienced with providing regulatory oversight for clinical trials including multinational studies. This includes providing regulatory review of study protocols, guidance on authoring responses to questions from Health Authorities and Ethics Committees to clinical trial applications, review and approval of Investigator Packages for Shipment of Clinical Trial Supplies.

Regulatory Operations Support

Electronic submissions are becoming mandatory in all key regions. Our team includes specialists in electronic submissions in CTD format, and project management professionals to support complex submissions. Our collaboration with a lead electronic publishing vendor would enable fully supporting your electronic publishing requirements.

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.