Speid & Associates

Speid & Associates is a private regulatory affairs and drug development consultancy serving pharmaceutical, biotechnology, and healthcare product companies. The firm provides strategic support across the development lifecycle, including regulatory strategy, IND-enabling development, clinical development planning, FDA and EMA interactions, CMC support, and commercialization-oriented market access guidance. Its capabilities span new chemical entities, biologics, 505(b)(2) applications, diagnostics, devices, injectables, and solid dosage forms. Rather than developing its own therapeutic pipeline, the company operates as a specialist advisory business led by founder and president Dr. Lorna Speid, helping sponsors advance products from early development through approval.