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Regulatory & CMC Advisory

Regulatory Strategy for Clinical Waiver

We help biosimilar developers build a scientifically defensible, totality-of-evidence case that supports a clinical waiver, streamlining the path to regulatory approval.

A well-constructed regulatory strategy is central to demonstrating biosimilarity without relying on large, costly clinical efficacy trials. Our team works alongside your development program to design and justify an analytical and functional similarity package strong enough to support a clinical waiver, while preparing the CMC documentation regulators expect to see. Below is an overview of what this service covers.

1

Analytical similarity strategy design for semi-regulated and regulated markets

2

Reference product selection strategy

3

Statistical similarity assessment (equivalence / quality range approach)

4

Totality-of-Evidence dossier building

5

Clinical waiver justification based on analytical and functional similarity

6

CMC module preparation (Module 3)

7

Gap analysis for regulatory submission

8

Pre-submission consultation support