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