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Oligonucleotide CMC

Oligonucleotide Discovery

Oligonucleotide CMC

Oligonucleotide Conjugate

Oligo Monomer & Ligand

CMC-Filing

API-Oligo

Drug Product

Analytical

API-PMO

CMC-Filing

210+

CMC submission packages written since 2019

A global RA CMC team experienced in regulatory dossiers preparation for IND, IMPD and NDA submissions with US FDA, EMA and China NMPA

Streamlined CMC writing integrated as part of the project team

Project Initiation: Provide RA consultation for phase and modality appropriate, country specific project scope and strategy

Project Execution: Provide filing template, collect data once testing completed. Finish section writing along different phases and perform timely data review with clients to mitigate potential risks

Project Completion: Complete submission-ready CMC dossiers

Phase appropriate RA CMC filing strategies tailored to oligo drug characteristics

Adopt principles of ICH Q3 (impurities) and Q6 (specifications) to oligo and peptide based on our experience with O&P IND and NDA