Reduce costs with a phase-dependent CMC development strategy

During the Early Stage of CMC development, you set the foundations for the Late Stage development which can save tremendous amount of time and money. Also, a sound scientific based CMC package at Early Stage is an asset generating value for your organization.

CMC & More supports you to:

set those foundations and develop a strategic CMC plan along the non-clinical and clinical plan (Phase I up to commercialization
identify the early wins for the future valuation of your company
bring your CMC package through its next approval

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To consider

Phases described are based on standard development path and vary depending on the nature of the product and regulatory pathway agreed with authorities.
The list of phase dependent activities is not exhaustive. Contact CMC & More for further informations!

Preclinical

Characterization DS solid state
DP Formulation development
Analytical method development
Pre-selection of quality attributes
Selection of CDMO
Tech transfer to GMP environment
Preparation of IND/CTA for Phase I

First-In-Human

Management CDMO for Phase I GMP material
Development of design space with preliminary characterization studies
Identification of Critical Process Parameters
Identification of Critical Quality Attributes
Preparation of CTA/IND for Phase IIa/IIb

Phase IIa/IIb

Scale up and eventually tech transfer
Process development using QbD principles and increase product knowledge
Qualification & validation of analytical methods
Justification of specifications
Preparation of IND/CTA for Phase III

Phase III

Process validation strategy
Full validation of analytical methods
Commercial specifications with justifications of limits
Setting shelf life
Preparation of NDA/MAA for commercialization

Commercial

Finalization of process validation with full commercial batches
Transfer to commercial production site, if not already done
Continuous improvement – implementation of Life Cycle changes

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