Bioanalytical Services in USA (1)

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Services
BIOANALYTICAL
Best clinical data management company in USA
Novum Canada is a one stop solution to all your
regulatory bioanalytical needs supporting the
development of pharmaceuticals and biosimilars.
With over 15 years of extensive experience, our
scientists will partner with your team to develop
robust assays for parent drug and metabolites.
The team will develop robust and reproducible
methods meeting your sponsor and regulatory
requirements. Our commitment and focus to quality
are re ected through our processes and systems.
Scienti c Affairs
Phase I Early Clinical Development
Bioanalytical
Novum Canada has been involved in conducting over
400 assays involving small and large molecules
supporting pharmacokinetic, toxicokinetic,
studies in our state of art GLP compliant
facility. Our scientists routinely develop and
validate methods and analyze over 15000 samples a
month. We have developed complex to proprietary
methods, for generic and NCE molecules, which
include sub picogram detection, endogenous,
chiral and hormonal assays. We use state of the
art automation systems in our lab including EDC
and reporting process.
Phase II-IV Clinical Trial Management
Data Management
Our team will work closely with you and provide
quick turnaround time ensuring operational e
ciencies and quality of data. Core expertise
includes developing and validating methods that
are robust and reproducible, and employing these
methods in a high throughput environment to
accelerate development times for prescription
medicines (Rx drugs) and generics. With
state-of-the-art instrumentation, we are one of
the leading bioanalytical providers in the
industry. We strive to deliver data which exceeds
quality standards and will stand scrutiny to
regulatory requirements Bioanalytical
Services Method Development Method Validation
Pharmacokinetic (PK) Analysis Bioavailability
Studies Bioequivalence Studies Large Molecule
analysis Short and long term sample storage with
an online monitoring and warning system
LARGE MOLECULES / THERAPEUTIC PROTEINS /
BIOSIMILARS
SMALL MOLECULES
IMMUNOGENICITY ASSESMENT
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Find out how Novum can make the di erence on your
next clinical trial.
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