Veeda's experience and commitment to scientific excellence makes it a Partner of Choice for NCE method development and bioanalysis. Its proven track record of systems compliance, high throughput capability and efficient project management are some of the examples which make Veeda an ideal partner for highly demanding, generic development programs.

1. Bioanalytical Capabilities
Veeda CR Laboratory, in Ahmedabad, India, is a premier facility offering pharmacokinetic parameters. It also involves the fully automated (using a
bioanalytical services to the Pharmaceutical sector. Veeda’s analytical services digital interface) transfer of resulting concentrations into WinNonlin for PK
encompass development, transfer, validation and application of bioanalytical analysis. All these parameters are 100% error-free as they do not involve
methods for small molecule bioanalysis for both NCEs and generic manual processing.
pharmaceuticals in various biological matrices, for e.g. plasma, blood, urine
All freezers are centrally monitored through a fully validated and 21 CFR Part
and tissues. Laboratory analyses may either be stand alone (we assay
11 compliant system (Eurotherm) and are backed up by a generator. All critical
samples generated by third-party clinics) or support studies conducted at one
systems such as LC¬MS/MS, gas compressors and IT systems are
of Veeda’s experienced clinical facilities. additionally supported by UPS.
Veeda’s experience and commitment to scientific excellence makes it a Partner In the bioanalytical department, we have more than 100 scientists, with five
of Choice for NCE method development and bioanalysis. Its proven track bioanalytcal investigators, and a dedicated team of bioanalytcal quality
record of systems compliance, high throughput capability and efficient project monitors.
management are some of the examples which make Veeda an ideal partner for
highly demanding, generic development programs. Experience and Expertise
Veeda has positioned itself among the elite of the Global Analytical CROs by Our analytical management team has proven track record in method transfer,
underpinning its business ethos on outstanding communication, quality and validation and method development for generic compounds and NCE
delivery of service. Our proven track record in quality and regulatory molecules. Our analytical personnel include some of the most experienced
compliance is demonstrated by successful regulatory inspections from analytical staff in India.
USFDA, MHRA, AGES, AFSSAPS, ANVISA, MCC, WHO, DCGI etc and Veeda regularly exhibits scientific posters at major international conferences
consistent repeat business from our clients. including the AAPS, CVG, APA and PBA annual symposia.
Our Facilities Veeda understands that its success is determined by the quality and
Veeda has two bioanalytical facilities, covering 27,000 sq. ft, which are dedication of its staff and we have implemented staff development plans and
equipped with: appraisal systems designed to obtain the best from our staff and the best
possible service for our clients. Veeda’s bioanalytical laboratory has one of the
16 LC-MS/MS systems (API-5500, API-4000, API-3000, API-2000 and
lowest staff turnover rates in the Indian CRO market (less than 10% during 5
Waters Premier XEs)
years of operation).
Watson LIMS® data management
Automated sample preparation capability is available using Tomtec and
Method Development and Validation
Minivac systems. Our state-of-the-art bioanalytical facilities and our bioanalytical team expertise
High-throughput capabilities give Veeda CR the capacity to assay over in normal, reversed-phase and chiral LC, low-dispersion LC, column switching,
2,000 samples per day. derivatisation, multiple analyte determinations, metabolite quantification,
conventional and hybrid micro LLE and SPE sample extractions ensures
Veeda’s pioneering implementation of Watson LIMs was recognised through development of reliable and reproducible bioanalytical methods. At Veeda, our
the award of “Best Architecture of Implementation – Watson LIMS” in 2009. dedication to quality and robustness starts with sample preparation and
chromatography. We have devised and implemented a pre-method validation
Watson LIMS is a fully integrated, next-generation laboratory information
protocol that focuses on selectivity, reproducibility, accuracy, matrix effect,
management system, based on a single server application. watson LIMS
recovery and stability.
supports study design, sampler receipts, barcode labeling, scheduled
analytical runs,interfacing with instruments, analytical result regression, All methods employ calibrators at the beginning and at the end of the run and
analyzing and summarizing the resulting concentrations (as graphs, etc.), and use deuterated internal standards when available.
Unleashing thethe Power
Unleash Power of India

2. Unleashing the Power of India
At Veeda, our methods are validated in accordance with the lifetime of the project as a single point contact. In addition,
FDA May 2001, ANVISA, EMEA, and Health Canada there are dedicated quality monitors and dedicated support Service Offerings
guidelines through predefined validation protocols. Sponsor staff in vital areas, such as sample receipt and tracking to BA/BE Studies
specific validation requirements are also accommodated in ensure regulatory and GLP compliance at all stages of project First-in-Human Studies
addition to specific regulatory requirements. execution.
PK/PD Studies
Over 255 method validation studies have been completed to Quality Assurance and Regulatory Track Phase 1/2a
date, of which 33 are for NCEs. Additionally, research work Record PK Studies (Dose Response,
conducted at Veeda has been accepted by most internationally Steady State, Food Effect, DDI)
reputed scientific journals, for example, Journal of Rapid All activities of Veeda bioanalytical lab are subject to quality
assurance processes. Veeda’s independent quality assurance Controlled Substance studies
Communications in Mass Spectrometry, Journal of
(QA) unit assures the highest standard quality data for all QTc Studies
Chromatography B, and Journal of Chromatographic Sciences
projects conducted through its site qualification audits, system Renal Studies
Project Sample Analysis audits, in-process audits, retrospective audits, trend analysis Glucose Clamp Services
and by ensuring appropriate corrective actions for its findings.
Veeda’s robust bioanalytical methods and authentic validation Bio-Analytical Services for
data ensures smooth execution of project samples analysis. Veeda’s commitment to quality, stringent quality control and Small Molecules
Our robustness of the methods reflects in the less number of quality assurance processes ensure highest standard of Method development and
repeat analysis samples and high accuracy in incurred regulatory compliance of the projects executed as is evident Validation
samples reanalysis data. In line with current FDA from the successful inspections by different regulatory Pharmacovigilance Support
requirements, Veeda recommends that incurred samples are agencies, including USFDA and the WHO.
Services
run for all regulatory studies. We have established procedures
USFDA has inspected Veeda six times, with three of these
that ensure the incurred sample requirements reflect the study
being concluded without the issue of a 483 (in the remaining
requirements. The Veeda Difference
three, we received four observations that have since been
In the last 3 years at Veeda, the overall results of incurred cleared). Our lab has been approved by ANVISA for the last six India’s most experienced early
sample re-analysis (ISR) has been more than 97%. years to conduct studies for Brazilian regulatory filings. clinical development CRO
Alternatively, Veeda is more than happy to adopt any Not connected or owned by
The WHO has inspected our facility three times and MHRA,
scientifically justified or preferred client policy. any pharmaceutical company
AGES (Austria), AFSSAPS and MCC have all inspected once.
and entirely focused on Clinical
All these inspections were concluded very positively by the
Research
ISR samples analysed 0 - 20% > 20% > 50% respective inspectors, noting Veeda’s quality systems and
regulatory compliance. Operations in India, Belgium,
22000 0 - 97.1% 2.7% 0.2%
USA and Malaysia
Besides regulatory inspections, Veeda had 75 sponsor
Very low attrition rate
Report Writing inspections to bioanalytical lab facilities. These regular sponsor
inspections helps Veeda to ensure compliance to 6 successful US FDA Audits
After completion of method validation experiments and project
ever-changing regulatory environment and sponsor specific 2007 Frost and Sullivan's
samples analysis, well trained dedicated report writing group
requirements. "Partner of Choice" for phase I
ensures the preparation of final error free reports as per
studies
specific regulatory requirements. While preparing reports
Central Laboratories 2009 Frost and Sullivan’s
Veeda can use either its own standard template or can adopt a
client template. All reports are provided as per sponsor specific Considering its infrastructure, technical expertise, commitment “Clinical Research Organiza-
timelines to enable their regulatory filings in time. to quality and regulatory compliance and excellent project tion of the Year’’
management skills, Veeda has been selected as the central Trusted CRO partner to 10 of
Project Management laboratory for two of the five top global pharmaceutical the world’s top 15 Global
Entire project at Veeda is actively supported by a dedicated companies. Veeda receives their samples from their different Pharmaceutical Companies
project manager, who is a bioanalytical expert, throughout the investigator sites across the globe for bioanalysis.
A decision to use Veeda CR for your bioanalytical 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.
info@veedacr.com | www.veedacr.com
India • USA • Belgium • Malaysia
www.veedacr.com