CRO & CMO ọrụ

JYMed si CRO & CMO ọrụ n'ihi na gị peptide oru ngo

Ebe JYMed nwere ike na-akwado gị peptide oru ngo?

CRO & CMO ọrụ

JYMed nwere ike inye peptides '  API na peptide okokụre onunu ogwu mmepe maka gị oru ngo, dị ka n'okpuru:

[Peocess Development]

CQA

QBD

Development na mkpebi siri ike nke usoro

Optimization nke usoro

3 batches mmepụta na-amata ndị feasibility n'ọtụtụ elu

1-3 batches pilot ọnụ ọgụgụ mmepụta

akparamagwa

3 nkwado batches mmepụta

Ich Kwụsie ọmụmụ

Clinical Sample mmepụta

[Gbasara nyocha Development]

Development nke gbasara nyocha ụzọ nke yiri umi na nnwale

adịghị ọcha ọmụmụ

Development nke gbasara nyocha ụzọ: GC, IC, amino acid analysis, counter ion na idebe ihe ọcha na usoro

Establishment of nkọwapụta

Ọrụ Standard Nkwadebe

Nkwado nke gbasara nyocha usoro

[Regulation Documents]

Nchịkọta nke data na DMF ndochi

Regulatory Support n'ihu US FDA / EDQM


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