Quality is OUR Priority
Our Laboratory Sciences Compliance Group is focused on quality, as well as on delivering critical drug biomarker quantitation data throughout each drug development phase.
We provide you with:
- Regulated bioanalysis across a wide range of analytes, including small molecules, biologics, bioequivalence, bioavailability, drug to drug interaction studies, and oligonucleotides
- Process audits and facility inspections
- Quality management systems
- RQAP-GLP Registered Auditors actively involved in the U.S. and Canadian regulatory communities (SQA, PRCSQA, CCSQA)
- Risk assessment quality audit plans
- On-site inspections and study-specific audits
- In-house Regulatory Team to ensure trials are conducted per protocol and within ICH/GCP/CFR guidelines
- Vendor qualifications
- SOP management
- GLP recognition-compliant archiving
You may also be interested in the following:
Join Dr. Kaylyn Koenig, on November 30th, for a conversation about digital droplet PCR (ddPCR) in preclinical research, including how it compares to qPCR.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.