Quality Support for Generic Peptide Development

Comparative Analytical Quality

Analytical comparison of generic and reference listed drug impurity profiles and quality attributes.

Impurity Strategy

Impurity identification, classification and reference material development aligned with regulatory guidance for generic peptides.

Reference Material Support

Reference materials for impurity profiling, method development and comparative analytical studies.

Method Development

Analytical method development and validation for generic peptide drug substances and products.

Stability

Stability study design and analytical support for generic peptide regulatory submissions.