CMC Development

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Chemistry, Manufacturing, and Controls decisions made early in a program shape everything that follows, your timeline, your regulatory risk, and ultimately whether a therapy reaches patients on schedule. PharmiOnyx partners with pharmaceutical and biotechnology organizations to build CMC strategies that are scientifically sound, regulatory ready, and built for scale, across both small molecule and large molecule (biologics) programs.

Drawing on direct experience across CROs, global pharma, and biotech, including CSL Behring, AbbVie, Takeda, and Aquestive Therapeutics, we bring a practitioner's view to CMC, not a theoretical one. PharmiOnyx provides strategic design, protocol and document review, and oversight, execution is carried out by your internal teams, CDMOs, or testing labs.

Process and Product Development Strategy

We help define the CMC development pathway from early phase through commercial launch, including phase appropriate strategies for drug substance and drug product, critical quality attribute identification, and risk based development planning aligned to ICH Q8, Q9, and Q11.

Technology Transfer and CDMO Oversight

We design technology transfer plans between development sites, CDMOs, and commercial manufacturing facilities, and provide oversight during execution to minimize knowledge loss and support right first time outcomes. This includes vendor qualification support, technical agreement review, and oversight of transfer activities carried out by your team or CDMO.

Stability Program Design

We design ICH compliant stability programs, including protocol design, matrixing and bracketing strategies, and shelf life justification, and review ongoing stability data trends to support regulatory filings and post approval commitments. Stability testing itself is executed by your lab or testing partner.

Method Lifecycle Management

We provide strategic oversight of analytical methods across their full lifecycle, from development and qualification through validation, transfer, and post approval changes, ensuring methods remain fit for purpose as a program advances through clinical phases.

CMC Regulatory Documentation

We author and review CMC sections for IND, NDA, BLA, and MAA submissions, including drug substance and drug product sections, ensuring data packages tell a coherent, defensible scientific story that withstands regulatory scrutiny.

cGMP Quality and Audit Readiness

We support GMP readiness assessments, mock audits, and CDMO/testing lab audits, helping organizations identify and close gaps before a regulatory inspection finds them.

Lifecycle and Post Approval Change Management

We help manage CMC changes after approval, including comparability protocol design and global regulatory change strategy, so growth does not outrun compliance.

Who we work with: virtual biotechs preparing for first in human studies, mid size biotech companies scaling from clinical to commercial manufacturing, and pharma organizations managing complex CDMO networks who need an experienced outside perspective without the overhead of a full time hire.