Opus Regulatory

Executive Summary

Opus Regulatory is a specialized consulting firm founded in 2017, offering regulatory affairs and quality services to pharmaceutical, biotechnology, and medical device companies. With a fully remote team of over 100 experienced professionals, the company provides deep expertise across five core pillars: Regulatory Strategy, Chemistry, Manufacturing, and Controls (CMC), Labeling, Advertising and Promotion, and Medical Review & Medical Information. The firm serves clients at various stages of product development, from early-stage to commercial. Operating out of San Diego, Opus Regulatory positions itself as a strategic partner for navigating complex regulatory landscapes, leveraging its team’s collective experience to accelerate client timelines and ensure compliance. The company’s flexible, remote model allows it to attract top talent and scale efficiently, supporting a diversified client base across multiple therapeutic areas.

Upcoming Catalysts (preview)

• Q3 2026Expansion into Gene and Cell Therapy Regulatory Services70% success
• TBDMajor Pharma Master Services Agreement50% success
• Q4 2026Launch of AI-Powered Regulatory Submission Platform40% success