About NSF Pharmalytica
NSF Pharmalytica provides
accurate, reliable, timely and cost-efficient contract analytical
and manufacturing solutions to pharmaceutical and chemical industry
clients. Our laboratories operate under full GLP and GMP compliance,
are FDA registered and inspected and DEA licensed to handle, store
and test Controlled Substances (Schedule I thru V).
NSF
International Acquires Pharmalytica Services,
LLC
Announcement: NSF International Acquires Leader
in Pharmaceuticals and Biotechnology
www.nsf.org
Extractables & Leachables
Collaboration
Announcement: NSF Pharmalytica and Dr.
Michael Ruberto of Material Needs Consulting have joined forces.
www.materialneedsconsulting.com
We are a single source provider for your Drug Substance CMC
section of your IND/CTA, NDA/MAA, DMF or ANDA; we provide a full
range of GMP analytical services, including global stability
programs, method development and validation, raw material release,
drug substance and impurity characterization. In addition, we are a
single source analytical provider for your Drug Product CMC section
of your IND/CTA, NDA/MAA, or ANDA.
We offer both First-In-Human and Bioequivalency clinical trials
through our established relationships with multiple clinical
CROs.
Our Pre-clinical GLP services include pre-clinical formulation
development, GLP analytical and bioanalysis support for toxicology,
metabolism and clinical trials.
Our EPA GLP services include conducting and supporting
Environmental-Fate, worker exposure and leach rate studies.
In addition, we offer expert consulting and training in many
areas, such as, GLP/GMP compliance, meeting CMC regulatory
submission requirements, equipment qualification, process safety and
facility audits.
New USP <467> Residual Solvents procedure! NSF Pharmalytica is
ready! Click the following link for more information.
New USP <467> Residual Solvents
procedure
Our most recent FDA inspection was January 2006. No 483's were
issued. View our most recent FDA inspection
results.
Please browse our website to learn more about how NSF
Pharmalytica can help you succeed!
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