PO Q1 2021 - 19
SinceSince
1975,
Moravek has been trusted by leading pharmaceutical companies
1975, Moravek has been trusted by leading pharmaceutical
and research institutions to provide quality labeled compounds to support any
and research institutions
to discovery
provide quality
labeled compounds
stagecompanies
of drug development,
from drug
to clinical
trials.
for research.
A short
list oflist
ourofcomprehensive
services
include:
A short
our comprehensive
services
include:
¾ GMP
[14C]
API
GMP
[14C]
APIManufacturing
Manufacturing
usein
in clinical
clinical trials
ForFor
use
trials
TechnicalBatch
Batch Synthesis
Synthesis
¾ Technical
Used to confirm synthetic pathway viability, establish radiolabeled compound stability, and provide material suitable for
Used to confirm synthetic pathway viability, establish radiolabeled compound stability, and provide material
non-clinical and pre-clinical use
suitable for non-clinical and pre-clinical use
GMP HPLC Method Transfer, Development and Validation
¾ GMP
HPLC
Method
Transfer,
Development
and Validation
Including
system
suitability
carried out
utilizing eleven qualified
HPLC and UPLC systems
Including system suitability carried out utilizing eleven 21 CFR Part 11 compliant HPLC and UPLC systems
GMP Analytical Services
NMR
of various nuclides,
MS, GC/MS, LC/MS, HPLC, UPLC, ICP-MS, GC-headspace, XRPD, Karl Fischer and other analytical
¾ GMP
Analytical
Services
services available
NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UPLC, ICP-MS, GC-headspace, XRPD, FTIR,
Karl
Fischer
and other
analytical
services
available
Quality
Assurance
Release
of [14C]
API under
GMP conditions
Quality Assurance review and approval of all GMP production and analytical documentation prior to release of API for use
¾ Quality
Assurance
Release of [14C] API under GMP conditions
in clinical
trials
Quality Assurance review and approval of all GMP production and analytical documentation prior
release
GMP Temperature
Controlled
Stability
to
of API for use
in clinical
trials Studies
o
¾
Stability studies at controlled room temperature, +4, -20 and -80 C utilizing Rees Scientific temperature, pressure, and
humidity
monitored controlled
environments
GMP
Temperature
Controlled
Stability Studies
Stability
studies atLogistics
controlled
temperature,
Comprehensive
androom
Related
Services +25°C/60% RH, +4°C, -20°C and -80°C
utilizing
Rees
Scientific
temperature,
pressure,
andshipping
humidity
monitored
controlled
environments
Storage, chain of custody, dispensing, collaboration with and
to clinics
worldwide,
temperature
tracking, etc.
¾ Comprehensive Logistics and Related Services
Storage, chain of custody, dispensing, collaboration with and shipping to clinics worldwide, temperature
tracking, etc.
577 Mercury Lane
Brea, CA 92821
577 Mercury Ln, Brea, CA 92821
p. 714-990-2018
p. 714-990-2018
f: 714-990-1824
f. 714-990-1824
info@moravek.com
info@moravek.com
www.moravek.com
www.moravek.com
http://www.moravek.com
PO Q1 2021
Table of Contents for the Digital Edition of PO Q1 2021
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