Universal Regulatory, Inc

Overview

Universal Regulatory, Inc (URI) provides consulting services in Regulatory Affairs, Regulatory Operations, CMC, Clinical Development and Clinical Operations; combining strong technical expertise in pharmaceutical development with knowledge of global regulatory environments.

We have a successful track record, having worked with ~40 pharmaceutical and biotechnology companies.

URI has established partnerships with consulting firms in EU, Japan, Asia to be able to support client needs for a global development program.

Our service areas include IND, DMF/VMF, CTA, NDA/MAA preparation and review, and life-cycle management, regulatory oversight of global clinical programs, strategic planning, due diligence activities, interactions with health authorities.

Standards & Methodologies

Our Expertise

Therapeutic Area Expertise

Oncology

Analgesia

Anti-Infectives

Gastrointestinal

Renal

Technology Platform Expertise

Small Molecules

Recombinant Proteins

Monoclonal Antibodies

Oligonucleotide and Gene Therapy

Combination Products

Medical Devices

Controlled Substances

Liposomal Technology

Controlled Release Formulations

Qualifications, Certifications, Accreditations & Licenses

URI's areas of specialization include 505(b)(2) submissions, biosimilars development, controlled release therapies, nasal and inhaled therapeutics, fixed-dose combinations, drug-device combinations, oligonucleotide/gene therapy, controlled substances

Our therapeutic area experience includes Oncology, Pain, Autoimmune diseases, Antimicrobial/Antiviral, Diabetes