BIOANALYTICAL METHOD DEVELOPMENT
Develop bioanalytical methods for pharmaceutical active ingredients,
metabolites, and adjuvants from matrices including plants,
animals, and humans. We support Phase I – III clinical studies,
as well as post market surveillance.
IMPURITIES IDENTIFICATIONS
Develop analytical methods, identify and characterize or certify
impurities in technical grade active ingredient, formulations,
and biological matrices.
METHOD VALIDATIONS
Validate analytical and bioanalytical methods, from straightforward
method transfer demonstrations to comprehensive evaluations
of accuracy, precision, repeatability, ruggedness, freeze-thaw,
and stability.Validated
Methods
ADME, PK/PD, METABOLISM AND TOXICOLOGY SUPPORT
Provide bioanalytical support for ADME, PK/PD, metabolism
and toxicology investigations.
BULK DRUG CHARACTERIZATIONS AND QC SUPPORT
Support raw materials qualification, in-process batch analysis,
finished product testing, and process troubleshooting, including
turn-key support from method development or optimization through
issuing certificates of analysis.
OCCUPATIONAL EXPOSURE AND STEWARDSHIP
Analytical chemistry support for occupational exposure and
facilities decontamination. Method development and residue
analytical support for matrices including biofluids, detergent
wash water, dosimeter pads, and inhalation monitoring capsules.
REPORTING AND QUALITY ASSURANCE
Our in-house QA department assures the integrity of all the
data we generate and of all the reports we publish. For analytical
studies, we often write protocols on behalf of sponsors, provide
study direction for laboratory projects, and write progress
reports and final reports. We provide reports in a wide range
of paper formats as well as electronic submission formats
including MS Word (.DOC) and Adobe Acrobat (.PDF).
Pharmaceutical
Capabilities.pdf
