JYMed can provide peptides’ API and peptide finished dosage development for your project, as below:
[Peocess Development]
CQA
QBD
Development and determination of process
Optimization of process
3 batches production to assess the feasibility to scale up
1-3 batches pilot scale production
Characterization
3 validation batches production
ICH Stability study
Clinical Sample production
[Analytical Development]
Development of analytical methods of related substance and assay
Impurity study
Development of analytical methods: GC, IC, amino acid analysis, counter ions and hygiene methods
Establishment of Specification
Working Standard Preparation
Validation of analytical method
[Regulation Documents]
Summary of data and DMF filling
Regulatory Support in front of US FDA/EDQM