FORMULATION & CHARACTERIZATION
FORMULATION & CHARACTERIZATION
1: Pharmaceutical evaluation and lead compound optimization.
2: Strategic guidance and management services from API and formulation sourcing through manufacturing, scale-up, and packaging.
3: Characterization of the starting material definition and regulatory excipients.
4: Scientific overview of API and drug product physicochemical characterization.
5: Development, optimization, and validation of analytical methods according to ICH to ensure a quality target product profile.
6: Definition of release and stability test specifications.
7: Potency testing strategy and impurity testing.
8: Immunogenicity risk management plan.
9: Full particle analysis in nanocomplex-based products.
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