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Small Molecule Analytical Chemistry

Activities By Development Phase

TEST ACTIVE PHARMACEUTICAL PRODUCTS FASTER AND MORE EFFICIENTLY
Catalent Benefits      Catalent Services

Catalent utilizes a step-wise approach for analytical testing. The activities completed are appropriate to the phase of the drug development. Analytical activities will be completed with reference to International Conference on Harmonization (ICH) requirements, or any globally relevant regulatory guidance, whenever appropriate.

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CATALENT BENEFITS

To ensure your project’s success, we are committed to providing:

  • Single point of contact for all phases
  • Assurances that current guidance’s are met
  • Effective communication

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Catalent Services

Preclinical

  • Non-GMP
  • GLP
  • Preformulation and solid state characterization

Early Phase Clinical

  • Phase-appropriate validation
  • Assessment of prototype formulations
  • First-in-man studies
  • Clinical trial material

Late Phase Clinical / Pre-Commercial

  • Registration
  • Design of experiments/Quality by design
  • Process validation
  • Photostability
  • Temperature excursions/Shipping studies
  • Shelf-life, expiry dating
  • Packaging component assessment/interactions

Commercial

Phase IV / Line Extension