Veeda CR Laboratory
located in Ahmedabad, India is a Premier
Bio-analytical facility offering
bio-analytical services to the
Pharmaceutical Sector. Veeda’s analytical
services encompass development, transfer,
validation and application of bio-analytical
methods for small molecule bio-analysis for
both NCEs and generic pharmaceuticals.
Laboratory analyses may be either stand
alone whereby we assay samples generated by
third party clinics or else in support of
studies conducted at one of Veeda’s
experienced clinical facilities.
Veeda does not seek to compete with other
Indian CROs on price alone and looks to
position itself among the elite of the
Global Analytical CROs by underpinning it’s
business ethos on outstanding communication,
quality and delivery of service.
Our proven track record is demonstrated by
strong growth in repeat business from some
of the largest Global Pharmaceutical
companies.
Veeda’s experience and commitment to
scientific excellence makes it the ideal
partner for NCE method development and
bio-analysis, while high throughput capacity
facilitates demanding generic programs.
A decision to use Veeda CR for your
bio-analytical requirements is therefore a
decision to select a CRO which operates to
the highest possible standards of quality,
expertise and delivery, but with the cost
advantage of working with an Indian CRO
partner.
Experience and Expertise
Our analytical management team have
collectively more than 45 years of
bio-analytical experience including method
transfer, validation and de novo method
development for generic compounds and NCE
molecules. Our analytical personnel
comprises of some of the most experienced
analytical staff in India.
In-house expertise includes normal, reversed
phase and chiral LC, low dispersion LC,
column switching, derivatisation, multiple-analyte
determinations, metabolite quantification,
conventional and hybrid micro LLE and SPE
sample extractions.
Veeda has significant experience of LC-MS/MS
with UPLC and sample preparation techniques
and strategies. In particular we have
significant in-house experience of
ionisation suppression avoidance strategies.
Over 195 method validation studies
have been completed to date of which 20 were
for NCEs.
Additionally, research work conducted at
Veeda has been accepted by most
internationally reputed scientific journals,
for example, Journal of Rapid Communications
in Mass spectrometry, Journal of
Chromatography B, Journal of Chromatographic
Sciences.
Veeda regularly exhibits scientific posters
at major international conferences
including the AAPS and PBA annual symposia.
Veeda understands that its success is
determined by the quality and dedication of
its staff and we have implemented staff
development plans and appraisal systems
designed to obtain the best from our staff
and the best possible service for our
clients. Veeda’s bio-analytical laboratory
has one of the lowest staff turnover rates
in the Indian CRO market (less than 5%
during 5 years of operation) and has a
current staff compliment of 92.
Method Development
At Veeda, the fundamental principles of
good method development are underpinned by
the philosophy that quality and robustness
starts with the sample preparation and
chromatography. We have devised and
implemented a pre-method validation protocol
which focuses on selectivity and
reproducibility rather than precision at the
LLOQ and ULOQ as the only end point.
At Veeda, we will not compromise your
samples by subjecting them to a poorly
developed method. All methods employ
calibrators at the beginning and end of the
run and use deuterated internal standards if
available.
Validation
All methods are validated to the FDA May
2001 guidelines as clarified by the 3rd
AAPS/FDA Bio-analytical Workshop, (May 1–3,
2006).
In line with current FDA requirements, Veeda
recommends that incurred samples are run for
all regulatory studies. We have established
procedures that are designed to ensure that
incurred sample requirements reflect the
study requirements. Alternatively we are
more than happy to adopt any preferred
client policy.
Veeda has successfully passed three WHO
audits, four FDA audits, one MHRA audit,
three ANVISA audits and over 150 client
audits. .
Project Management
A Study at Veeda is supported by a
dedicated project manager throughout the
lifetime of the study. In addition, there
are dedicated quality monitors and dedicated
support staff in vital areas such as sample
receipt and tracking.
Report Writing
Veeda has a dedicated report writing group
which works either as a stand alone service
or in support of studies conducted at other
Veeda CR facilities. Veeda can use either
our own standard template or can adopt a
client template if required. Draft
analytical reports are available two weeks
after the completion of bio-analysis.
Facilities
Equipment is currently includes: 2 Sciex
API 2000s, 3 API 3000s, 3 Waters Premier XEs
and 5 API 4000s, interfaced with traditional
LC, microbore LC or UPLC systems. APCI and
ESI ionisation are available. Automated
sample preparation capability is available
utilising Tomtec and Minivac systems.
High throughput capabilities give Veeda CR
the capacity to assay over 2000 samples per
day.
Veeda was a pioneer in India for the
implementation of Watson LIMs and have been
awarded the “Best Architecture of
Implementation – Watson LIMS” (2009) By the
Second Thermo Scientific Laboratory
Symposium (LIS) India.
All freezers are centrally monitored through
a fully validated and 21 CFR Part 11
compliant system and are backed up with a
generator.
All critical systems such as LC-MS/MS, gas
compressors and IT systems are additionally
supported by UPS.
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