Oligonucleotide CMC made easy
We support you along all phases of drug development, from defining the right strategy to submitting your regulatory applications.
Your strategy is our mission, your success is our priority.
Our Services
Manufacturing and analytical strategy
Regulatory Interactions
On demand support
Without a proper guideline dedicated to oligonucleotides, interaction with regulators can become a challenge. We help from early strategy conception to the preparation of the necessary briefing packages, dossier writing, review, and conversion (EU IMPD to/from US IND).
Do you face a new dossier and need help processing or authoring certain sections? Is one of your team members suddently indisposed and you need to cover without time to explain the specifics of oligonucleotides? Is a new candidate on the pipeline and no available bandwith? Do not worry, we support when support is needed: make the call, we deliver.
Setting the proper manufacturing and analytical strategy is key to a straightforward development. From early CMO scouting and selection, through proof-of-concept batches, effective process development, upscale and validation, to the development of analytical methods, comprehensive controls strategies, and phase dependent specifications, we support you at all stages.