Regulatory Roadmap & Pathway Selection
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Regulatory Roadmap & Pathway Selection

Navigating the Complex Maze of Global Approvals

Overview

Choosing the right regulatory pathway can mean the difference between a swift approval and years of delay. Whether it's a standard 505(b)(1), a streamlined 505(b)(2), or a biosimilar pathway, we analyze your asset to determine the most efficient route to market. Our roadmaps provide a step-by-step guide through the regulatory landscape, anticipating hurdles before they appear.

Key Features

Pathway feasibility analysis (505(b)(1), 505(b)(2), BLA)
Global submission sequencing
Expedited program eligibility assessment
Pediatric requirement planning

Our Process

1

Asset Review

Deep dive into your molecule's characteristics and available data.

2

Pathway Identification

Matching your asset with the most advantageous regulatory mechanisms.

3

Strategic Mapping

Developing a timeline of interactions, submissions, and data requirements.

Project Complete & Deliverables Provided

Frequently Asked Questions

A 505(b)(1) NDA requires you to conduct all of your own studies to demonstrate safety and efficacy—essentially starting from scratch. A 505(b)(2) allows you to rely on the FDA's previous findings for an approved drug (the 'listed drug') to support some of your application. This can significantly reduce clinical trial requirements. For example, if you're developing a new formulation or dose of an existing molecule, 505(b)(2) might only require bioequivalence studies instead of full Phase 3 trials.

Why Choose Us

  • Accelerated time to market
  • Optimized resource allocation
  • Clear visibility of critical milestones
  • Strategic alignment across regions

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What Our Clients Say

"Our development timeline was cut by nearly 18 months thanks to the 505(b)(2) strategy Adelphi identified. They saw an opportunity we had completely missed and built a compelling case that the FDA accepted."

James Chen, PhD

Chief Development Officer

Mid-Size Pharma

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Pre-IND / Pre-CTA Meetings

Expert preparation and representation at critical health authority meetings.

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Pediatric Study Plans (PSP/PIP)

Strategic development of pediatric plans to meet FDA and EMA requirements.

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