AdvancingDrugs is a team of drug development experts and contract service providers (CRO / CMO) that provide all the contract services to advance your lead candidate through IND & NDA submissions.
*We specialize in custom API manufacturing from gram quantities to metric tons for pharmaceutical drug development and scale up.
*We also specialize in PK, Bioavailability & GLP Toxicology and Safety Contract Services
Non-GLP Exploratory Study in Mice
Non-GLP Exploratory Study in Rats
Maximum Tolerated Dose Studies
Range Finding Studies
Exploratory Toxicology Studies
7-day Repeat Dose Studies in Rodent, Dog, Minipig and Non-human Primates
14-day Repeat Dose Studies in Rodent, Dog, Minipig and Non-human Primates
28-day Repeat Dose Studies in Rodent, Dog, Minipig and Non-human Primates
Safety Pharmacology Studies (CV, Respiratory, CNS)
Genetic Toxicology Studies (Ames, Micronucleus, Chromosomal Aberration)
Analytical Method Development and Sample Analysis
Rodent PK Studies
Dog PK Studies
Non-human Primate PK Studies
Analytical Method Development
HPLC Sample Analysis
Mass Spectrometry Analysis
Small molecule synthesis and process scale up to support your drug development requirements. We provide gram quantity for early drug development up to metric tons for commercial production.
We provide solutions to the most challenging synthesis & formulation issues facing drug developers. We routinely address issues with scale up, insoluble compounds, covalently bonded compounds and bioavailability.
Our relationships with highly experienced CMOs are well-suited for drug developers faced with synthesis & formulation issues. As such, we can match you with the best CMO to fit your needs while providing you an excellent cost benefit for optimizing the best drug development product possible: whether it be a spray drying formulation to solve your bioavailability problem or a more efficient manufacturing process, we have relationships with the most talented and capable CMO in the industry.
We support you through the preclinical drug development process by managing your project and insuring filings are done correctly and on time.
We provide the most cost effective toxicology & safety pharmacology services in the industry -- period.
Our long tenure in the preclinical industry has created relationships and awareness of all of the quality CROs in North America. As such, we can match you with the best CRO to fit your needs while providing the best pricing possible: whether it be more personal interaction or ironclad deliverables, we have the relationships and business agreements in place to deliver.
Project management is available to insure your preclinical toxicology program stays on track and your IND submission is filed correctly.
ADME/DMPK Studies Services
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