Agilent is dedicated to current Good Manufacturing Practices (GMP) as defined by the International Conference on Harmonisation (ICH) for providing Active Pharmaceutical Ingredients. Our Quality Policy and robust quality systems incorporate established ICH Standards, as well as other applicable guidelines, enabling us to provide oligo API world-wide.
Our experienced team of compliance specialists is lead by a former FDA Field Investigator and can provide assistance with the Chemistry, Manufacturing and Controls (CMC) for US and International regulatory submissions (DMF, IND, CTA, NDA).
- Over 60 successful compliance audits by small biotech to big pharma
- On-site FDA visits including CDER and Denver District
- Quality by Design
- GMP compliant testing of raw materials, in-process samples, final APIs and drug product – Watch a short video and learn more
- Full release testing of APIs and finished product in-house – Watch a short video and learn more
- Qualified mass-spec instrumentation and validated methods to assure quality, purity, identity and strength
- Industry accepted risk-based approach to drug development following ICH Q8 and Q9 guidance
- Unparalleled analytical capabilities from the world’s premier analytical company, enable in-house testing and improved timelines for our clients (Watch a short video to learn more)
Watch this short video to learn more.
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