Partner with A2-Ai for vendor selection, oversight, and design of
development stage-appropriate analytical methods. We can help with
method development and validation support from discovery screening to
late-stage clinical studies. Work with us for complete bioanalytical
method development supporting all therapy modalities:
- Small molecules
- Antibodies
- ADCs
- Proteins
- Nucleotides
- Cell therapies
We are experienced with many modalities, including:
- Ligand-binding assays, PK and ADA
- LC-MS methods, small and large molecules
- Quantitative PCR methods
- Flow cytometry, PK and PD
IND Services
Our experienced Clinical Pharmacologists and Medical Oncologists will
work with you to design your First in Patient (FIP)/First in Human (FIH)
study as a part of the IND package. Our Medical Writers will work with
your Subject Matter Experts to finalize the IND so that it is ready to
be submitted to the FDA (or other regulatory body). The A2-Ai team is
available for writing the pre-IND Briefing Document as well as attending
the pre-IND meeting with the FDA to defend the start dose and the dose
escalation strategy (Phase 1A).