Analytical Development

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 Analytical Development

Strong analytical methods are the foundation everything else in CMC depends on. Without a method that is accurate, robust, and stability indicating, you cannot characterize your product, release a batch with confidence, or defend your data in front of a regulatory agency. PharmiOnyx brings deep analytical chemistry expertise, built on a PhD in Analytical Chemistry and over a decade developing and overseeing methods across CROs and global pharma and biotech organizations, including CSL Behring, AbbVie, Takeda, and Covance.

We design analytical strategy, write and review protocols, and oversee execution carried out by your internal labs or qualified testing partners. PharmiOnyx does not operate its own laboratory, our role is strategic design, protocol and report review, and oversight, not hands-on sample testing.

Method Development Strategy

We design method development approaches across a range of platforms including HPLC, UPLC, LC‑MS/MS, GC, dissolution, and compendial and non compendial techniques, tailored to the molecule, the matrix, and the intended use of the data, for execution by your lab or testing partner.

Method Qualification and Validation Protocol Design

We design qualification and validation protocols aligned to ICH Q2(R2) and phase appropriate expectations, covering specificity, accuracy, precision, linearity, range, robustness, and stability indicating capability, and review the resulting data and reports for scientific soundness and regulatory defensibility.

Method Transfer Oversight

We design method transfer protocols and oversee transfer execution between internal labs, CDMOs, and testing laboratories, including comparative testing review and resolution support for discrepancies identified during transfer.

Troubleshooting and Root Cause Investigation Support

When a method is underperforming, drifting, or generating unexpected OOS or OOT results, we review data and investigation findings to help identify the true source of variability and guide your team or testing lab toward a durable fix.

Forced Degradation and Stability Indicating Method Strategy

We design forced degradation study protocols and stability indicating method strategies capable of resolving the drug substance or drug product from its relevant degradation products, a critical requirement for any regulatory filing, for execution by your testing partner.

Specification Setting and Justification

We help establish scientifically justified specifications based on process capability, stability data, and clinical relevance, ensuring specifications are defensible during regulatory review.

Compendial and Pharmacopeial Compliance Strategy

We support USP, EP, and JP compendial method verification strategy and compliance review, helping organizations navigate compendial requirements alongside method specific validation needs.

Analytical Strategy for Complex Molecules

For biologics and other complex modalities, we bring direct experience with structural characterization techniques including HDX‑MS and other mass spectrometry based approaches, supporting strategy development for higher order structure and conformational analysis where traditional methods fall short.

Who we work with: labs facing an unresolved OOS investigation who need an experienced outside review, biotech companies designing a method portfolio strategy ahead of a regulatory milestone, and organizations that need a second set of expert eyes on protocols, data, or reports tied to a method that "should be working" but isn't.

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