Accelerating Regulatory Success from Austin to the World.
Strategic guidance for pharmaceutical innovation. Navigating FDA & Global compliance with the agility of tech and the rigor of science.
Excellence That Speaks for Itself
Proven track record of regulatory success across therapeutic areas and global markets.
Every submission accepted on first review
Senior regulatory leadership at top pharma
Across multiple therapeutic areas
Comprehensive regulatory pathway expertise
Patented innovation for AMD treatment methodology
Therapeutic Areas of Expertise
The Path to Approval
Navigating the product lifecycle with precision.
Strategic Feasibility
Early-stage gap analysis and regulatory pathway definition to de-risk development.
Submission Readiness
Authoring and compiling IND/CTA, NDA/BLA, and MAA submissions with full eCTD compliance.
Agency Liaison
Direct representation and negotiation with FDA, EMA, and global health authorities.
Lifecycle Management
Post-market variations, labeling updates, and CMC change controls.
Comprehensive Services
End-to-end regulatory support from discovery to post-market lifecycle management.
Regulatory Strategy
- •Target Product Profile Development
- •Regulatory Pathway Selection
- •Pre-IND/CTA Meeting Preparation
CMC & Quality Compliance
- •Module 3 Authorship & Review
- •GMP Compliance Audits
- •21 CFR Part 11 Document Management
Led by Proven Expertise
Founded by experienced regulatory affairs professionals with over 50 years of combined experience navigating the complex landscape of pharmaceutical approvals.
Our team has achieved multiple NDA, BLA, NDS, and MAA approvals across therapeutic areas including orphan drugs, ophthalmology, infectious disease, and wound care—a testament to our ability to shepherd breakthrough therapies through the most rigorous regulatory pathways.
Agility Meets Compliance
Headquartered in Austin, Texas—a hub of biotechnology and innovation. We bring the agility of the tech sector to the rigor of pharmaceutical compliance.
While others are stuck in traditional consulting models, we leverage modern tools and adaptive strategies to keep your regulatory timeline moving forward.
Learn About Our Approach→Ready to Navigate Your Path to FDA Approval?
Let's discuss how Adelphi Biosciences can help accelerate your regulatory strategy. Schedule a free consultation with Peter Parsonson to explore your unique needs.
- Free 30-minute strategic consultation
- Same-day response guarantee
- No obligation assessment
- Confidential discussion
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