Analytical Services
Leveraging our group strengths we have an extensive range of analytical capabilities and services.
Services routinely offered in analytical support of clinical supplies:
- Analytical method development for comparator and innovator products in compliance with ICH requirements. Typical methods include identity, assay, dissolution, moisture testing and particle size analysis.
- Method transfer of analytical methods provided by our clients and third parties.
- Design and conduct of stability protocols for blinded and repackaged product. Almac offers stability storage under ICH compliant conditions (25ºC/60% RH; 30ºC/65% RH; 40ºC/75% RH).
- Comparative dissolution analysis of blinded versus unblinded products for use in clinical trials.
- Release testing in support of EU Release of clinical trial products.
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