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Analytical Method Development and Validation — Catalent

Catalent
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Scope with confidence. Review the published service details, then contact the CRO directly to confirm methods, timing, availability, and pricing.
Regulatory Services service category cover
Regulatory Services service category cover
  • Response Time
    Contact CRO
  • Delivery Time
    Project dependent
  • Location
    Somerset, NJ

About this service

What we bring

At Catalent, we develop, optimize, validate, and transfer analytical methods for release, stability, characterization, and regulatory use.

Working model

We define the engagement around molecule and dosage form, specification strategy, sensitivity, selectivity, impurities, platform, validation stage, and receiving laboratory.

Decision-ready deliverables

Sponsors can expect method protocols, development evidence, validation results, transfer documentation, and controlled procedures.

Program fit

This offering is intended for small-molecule programs that need phase-appropriate analytics built for later development and manufacturing.

Editorial note: Scope, availability, geography, and regulatory applicability should be confirmed directly with the provider. Official source reviewed: https://www.catalent.com/pharma/small-molecule/development/methods-development-validation

Common questions

What can be included in vendor quality oversight?

The proposed scope centers on quality-focused review and coordination of outsourced activities and responsibilities. Exact activities, methods, inputs, outputs, and responsibilities are confirmed with Catalent for the specific program.

Timing and pricing depend on project stage, complexity, required methods, available inputs, locations, quality requirements, and deliverables. Request a quote from the CRO after sharing a non-confidential project outline.

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