Regulatory Expertise, Boutique Excellence
Founded by Regulatory Affairs Professionals with multiple NDA, BLA, NDS, and MAA approvals, Adelphi Biosciences delivers boutique consulting with big-firm expertise.
Our Expertise
50+ Years of Combined Regulatory Experience
Our team brings deep expertise across multiple therapeutic areas including orphan drugs, ophthalmology, infectious disease, and wound care. With a Proven FDA submission success rate, we navigate complex regulatory pathways and deliver results for our clients.
Our Approach
Adelphi Biosciences combines deep regulatory expertise with boutique agility. We work as an extension of your team, providing hands-on guidance from experienced professionals who understand both the science and the regulatory landscape.
Orphan Drug Development
Deep experience navigating orphan drug designations and rare disease regulatory pathways.
Ophthalmology & Retinal
Extensive background in ophthalmic therapeutics including gene therapies and novel treatments.
Infectious Disease
Regulatory strategy for antimicrobial and antiviral product development.
Wound Care
Experience with advanced wound care products from development through commercialization.
Multiple
Orphan drugs, ophthalmology & more
NDA/BLA/NDS/MAA
Full spectrum expertise
50+ Years
Combined regulatory leadership
Therapeutic Expertise
Why Choose Adelphi Biosciences?
The boutique advantage: executive expertise without the big-firm bureaucracy
Who We Serve
Partnering with innovative companies across the life sciences industry
Biotech Startups
Pharmaceutical Companies
Life Science Investors
Emerging Pharma
The Austin Advantage
Austin has emerged as a major hub for life sciences innovation, with a thriving biotech ecosystem and proximity to world-class research institutions.
Being based in Austin allows Adelphi Biosciences to work closely with local biotech startups while serving clients nationwide. Our central time zone location makes collaboration easy with teams across the country.
Austin, Texas
Heart of Texas Life Sciences
Our Philosophy
At Adelphi Biosciences, we believe that effective regulatory strategy requires more than technical expertise — it demands a deep understanding of your business objectives and the agility to adapt as your program evolves.
Unlike large consulting firms where your project may be staffed by junior associates, when you work with Adelphi Biosciences, you work directly with experienced regulatory professionals. This ensures consistent, senior-level attention to your regulatory needs without the overhead and bureaucracy of larger organizations.
Ready to Work Together?
Schedule a complimentary consultation to discuss how Adelphi Biosciences can support your regulatory strategy.