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Bioanalytical Capabilities Veeda CR Laboratory, in Ahmedabad, India, is a premier facility offering bioanalytical services to the Pharmaceutical sector. Veeda’s analytical services encompass development, transfer, validation and application of bioanalytical methods for small molecule bioanalysis for both NCEs and generic pharmaceuticals in various biological matrices, for e.g. plasma, blood, urine and tissues. Laboratory analyses may either be stand alone (we assay samples generated by third-party clinics) or support studies conducted at one of Veeda’s experienced clinical facilities.

pharmacokinetic parameters. It also involves the fully automated (using a digital interface) transfer of resulting concentrations into WinNonlin for PK analysis. All these parameters are 100% error-free as they do not involve manual processing.

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.

In the bioanalytical department, we have more than 100 scientists, with five bioanalytcal investigators, and a dedicated team of bioanalytcal quality monitors.

Veeda has positioned itself among the elite of the Global Analytical CROs by underpinning its business ethos on outstanding communication, quality and delivery of service. Our proven track record in quality and regulatory compliance is demonstrated by successful regulatory inspections from USFDA, MHRA, AGES, AFSSAPS, ANVISA, MCC, WHO, DCGI etc and consistent repeat business from our clients.

Our analytical management team has proven track record in method transfer, validation and method development for generic compounds and NCE molecules. Our analytical personnel include some of the most experienced analytical staff in India.

Our Facilities

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 bioanalytical laboratory has one of the lowest staff turnover rates in the Indian CRO market (less than 10% during 5 years of operation).

Veeda has two bioanalytical facilities, covering 27,000 sq. ft, which are equipped with: 16 LC-MS/MS systems (API-5500, API-4000, API-3000, API-2000 and Waters Premier XEs) Watson LIMS® data management Automated sample preparation capability is available using Tomtec and Minivac systems. High-throughput capabilities give Veeda CR the capacity to assay over 2,000 samples per day. Veeda’s pioneering implementation of Watson LIMs was recognised through the award of “Best Architecture of Implementation – Watson LIMS” in 2009. Watson LIMS is a fully integrated, next-generation laboratory information management system, based on a single server application. watson LIMS supports study design, sampler receipts, barcode labeling, scheduled analytical runs,interfacing with instruments, analytical result regression, analyzing and summarizing the resulting concentrations (as graphs, etc.), and

All freezers are centrally monitored through a fully validated and 21 CFR Part 11 compliant system (Eurotherm) and are backed up by a generator. All critical systems such as LC¬MS/MS, gas compressors and IT systems are additionally supported by UPS.

Experience and Expertise

Veeda regularly exhibits scientific posters at major international conferences including the AAPS, CVG, APA and PBA annual symposia.

Method Development and Validation Our state-of-the-art bioanalytical facilities and our bioanalytical team expertise in 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 ensures development of reliable and reproducible bioanalytical methods. At Veeda, our dedication to quality and robustness starts with sample preparation and chromatography. We have devised and implemented a pre-method validation protocol that focuses on selectivity, reproducibility, accuracy, matrix effect, recovery and stability. All methods employ calibrators at the beginning and at the end of the run and use deuterated internal standards when available.

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At Veeda, our methods are validated in accordance with the FDA May 2001, ANVISA, EMEA, and Health Canada guidelines through predefined validation protocols. Sponsor specific validation requirements are also accommodated in addition to specific regulatory requirements.

lifetime of the project as a single point contact. In addition, there are dedicated quality monitors and dedicated support staff in vital areas, such as sample receipt and tracking to ensure regulatory and GLP compliance at all stages of project execution.

Over 255 method validation studies have been completed to date, of which 33 are 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, and Journal of Chromatographic Sciences

Quality Assurance and Regulatory Track Record

Project Sample Analysis Veeda’s robust bioanalytical methods and authentic validation data ensures smooth execution of project samples analysis. Our robustness of the methods reflects in the less number of repeat analysis samples and high accuracy in incurred samples reanalysis data. In line with current FDA requirements, Veeda recommends that incurred samples are run for all regulatory studies. We have established procedures that ensure the incurred sample requirements reflect the study requirements. In the last 3 years at Veeda, the overall results of incurred sample re-analysis (ISR) has been more than 97%. Alternatively, Veeda is more than happy to adopt any scientifically justified or preferred client policy. ISR samples analysed 22000

0 - 20%

> 20%

> 50%

0 - 97.1%

2.7%

0.2%

Report Writing After completion of method validation experiments and project samples analysis, well trained dedicated report writing group ensures the preparation of final error free reports as per specific regulatory requirements. While preparing reports Veeda can use either its own standard template or can adopt a client template. All reports are provided as per sponsor specific timelines to enable their regulatory filings in time.

Project Management Entire project at Veeda is actively supported by a dedicated project manager, who is a bioanalytical expert, throughout the

Service Offerings BA/BE Studies First-in-Human Studies PK/PD Studies Phase 1/2a PK Studies (Dose Response,

All activities of Veeda bioanalytical lab are subject to quality assurance processes. Veeda’s independent quality assurance (QA) unit assures the highest standard quality data for all projects conducted through its site qualification audits, system audits, in-process audits, retrospective audits, trend analysis and by ensuring appropriate corrective actions for its findings. Veeda’s commitment to quality, stringent quality control and quality assurance processes ensure highest standard of regulatory compliance of the projects executed as is evident from the successful inspections by different regulatory agencies, including USFDA and the WHO. USFDA has inspected Veeda six times, with three of these being concluded without the issue of a 483 (in the remaining three, we received four observations that have since been cleared). Our lab has been approved by ANVISA for the last six years to conduct studies for Brazilian regulatory filings. The WHO has inspected our facility three times and MHRA, AGES (Austria), AFSSAPS and MCC have all inspected once. All these inspections were concluded very positively by the respective inspectors, noting Veeda’s quality systems and regulatory compliance. Besides regulatory inspections, Veeda had 75 sponsor inspections to bioanalytical lab facilities. These regular sponsor inspections helps Veeda to ensure compliance to ever-changing regulatory environment and sponsor specific requirements.

Central Laboratories

Steady State, Food Effect, DDI) Controlled Substance studies QTc Studies Renal Studies Glucose Clamp Services Bio-Analytical Services for Small Molecules Method development and Validation Pharmacovigilance Support Services

The Veeda Difference India’s most experienced early clinical development CRO Not connected or owned by any pharmaceutical company and entirely focused on Clinical Research Operations in India, Belgium, USA and Malaysia Very low attrition rate 6 successful US FDA Audits 2007 Frost and Sullivan's "Partner of Choice" for phase I studies 2009 Frost and Sullivan’s

Considering its infrastructure, technical expertise, commitment to quality and regulatory compliance and excellent project management skills, Veeda has been selected as the central laboratory for two of the five top global pharmaceutical companies. Veeda receives their samples from their different investigator sites across the globe for bioanalysis.

“Clinical Research Organization of the Year’’ Trusted CRO partner to 10 of the world’s top 15 Global Pharmaceutical Companies

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

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Bio Analytical Capabilities - Bio-Analytical Services for Small Molecules