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Bioanalytical Services
Veeda CR is one of the India's leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our bioanalytical staff (more than 250) provides technical services to national and international Pharma companies. Bioanalytical has capacity to analyze >100000 samples per Month. Veeda bioanalytical has a proven regulatory track record and regulatory compliant environment to fulfill regulatory and sponsor's satisfaction.
Veeda clinical research provides bioanalytical services to support clinical studies. Our experienced scientists offer a full range of LC/MS/MS bioanalytical services, from method development, method validation, and sample analysis as per regulatory requirement. Veeda's familiarity and compliance with regulatory requirements of the U.S. Food and Drug Administration (FDA), EMEA, ANVISA and other agencies enable our clients to have complete confidence in the quality and acceptability of all analytical data. Veeda has 46 LCMSMS machines and can analyze samples using multiple machines thereby reducing the overall days of analysis in some timebound studies
- Method development and validation for a wide spectrum of drug substances
- Quantitative analysis at sub-picogram /mL concentrations
- Chiral Molecule Analysis.
- Complex bioanalysis of bound and Total drug
- Bioanalysis of conjugated and total drug (By enzymatic Process)
- Hormones and vitamin analysis.
Facility and Instrumentation :
State-of-the-art laboratory facilities for bioanalysis
- Latest Instrumentation/multiple equipments and technology to ensure project completion with quick-turnaround time.
- Access controlled Freezer room (for sample storage) with power back up and 24*7 temperature Monitoring and alarm system.
- Access controlled entry and exit facility.
- Separate sample processing laboratory.
- LC-MS/MS laboratory.
- ICP-OES laboratory.
- Large molecule/high end processing lab.
- LIMS-Watson LIMS (Laboratory information management System) for all bioanalytical data management.
- Veeda has 25 high end equipment’s to cater the low concentration required in special studies and also the requirement of low volume of Biological matrix due to ethical issues.
- Veeda has sensitive machines like Sh 8060, Sh8050 and API550 to achieve the pg levels.
Working Closely with Our Clients :
Veeda's technical, research, and development services meet the highest standards of professional performance to satisfy the unique requirements of our clients. We work closely with our clients to identify their requirements and clarify their expectations, including cost and time constraints. Veeda extends its excellence in research and technical services to its business systems and processes, making it easy for clients, subcontractors, and vendors to partner with us.
Our Capabilities :
- State of the art Bio-analytical Unit with more than 600 validated assays in its library of compounds, 50 NCE methods & 20 more under development.
- Team having experience in understanding the challenges of study design and logistics of study execution
- Proven regulatory track record with 11 USFDA, 5 European, 4 WHO & 7 ANVISA audits
- Trusted CRO partner to 10 of the world's top 15 Global Pharmaceutical Companies
- Veeda has the capability of handling NCE molecules and analyzing molecules which are received in small cohorts from across the globe. The timelines to complete the analysis in such cases is crucial since the decisions of further dosing or changing the dosing etc is to be taken on the results being these are exploratory studies.
| Segment | Veeda's Expertise | Molecule Experience |
|---|---|---|
| Vitamins & Hormones | - Since vitamins & hormones occur naturally in plasma, quantifying the impact resulting from drug intake is a challenging process; | Ethinyl Estradiol, Prednisolone, Unconjugated Estrone & Estradiol, Conjugated Estrone, Progesterone |
| Inhalation Products | - Veeda has the capability to detect, isolate, and quantify the extremely small quantities of inhalation drugs in a given biological matrix | Fluticasone, Formoterol, Tiotropium & Ipratropium. In the process of development of salmeterol Xinafoate, |
| Long acting Depot Injectable Suspension | Veeda has the capability to detect, isolate, and quantify the small peptides in a given biological matrix | Octreotide & Leuprolide In the process of development of Lanreotide. |
| Isomer Separation | - Experienced in the use of comples column chemistry to separate and quantify isomers | Cis & trans Phytonadione, R & S Ketoprofen, S-RRR Nebivolol and R-SSS Nebivolol, R & S Fluvastatin |
| Tricky molecules | Handle complex molecules - Stability issue, ionization issue and separation from metabolites | Penicillamine, Isosorbide dinitrate and its metabolites, Spironolactone, Bortezomib, 1,3,5 Trimethoxybenzene, Phloroglucinol |
| Liposomes | - Requires buffer addition to aliquots in precise amounts determined by plasma/serum separated from each sample | Method Validated for Free doxorubicin and Liposomal Doxorubicin, Method Validated for Free Amphotericin and under development for Liposomal Amphotericin |
| Ligand Binding Assay | Experienced in the use of ELISA technique for Biosimilar product | Insulin, C-Peptide, G-CSF, Para thyroid hormone (PTH) |
| Elemental Analysis | - Expertise in separation and quantification of Total Iron(TI) and Transferrin bound iron (TBI) as well quantification of potassium, magnesium etc. - 2 ICP machines used for the process | Total Iron(TI) and Transferrin bound iron (TBI), Magnesium, Lithium, Potassium |
| Equipment / Software | Numbers |
|---|---|
| LC-MS/MS | 46 |
| - API 5500 | 5 |
| - Shimadzu 8060 | 2 |
| - Shimadzu 8050 | 13 |
| - API 4000 | 12 |
| - Shimadzu 8040 | 4 |
| - API 3200 | 2 |
| - API 3000 | 3 |
| - API 2000 | 2 |
| - Quattro Premier | 3 |
| ICP-OE S | 2 |
| Micro-plate reader | 1 |
| Watson Lims | |
| * Eventually become 50 by 2019 end |
WHY PARTNER WITH VEEDA?
- Veeda is an Independent Indian CRO with 13 years of experience.
- Veeda has conducted over 2000+ studies for USFDA/MHRA/EU
- Veeda has over 900+ healthcare professional
- Veeda has worked with over 200 pharmaceutical companies around the world ,and has Master Service Agreements with many of the top global pharmaceutical companies
- We have over 600+ analytical methods
- Due to stringent quality norms and transparency at all stages , Veeda is considered a preferred partner with many of the Pharma companies. Approx 50 NCE molecules developed and validated so far and samples analysis done cohort wise in a very timely manner.
Our exemplary regulatory track record
USFDA
33 times
Brazil ANVISA
7 times
WHO
5 times
UK MHRA
3 times
EU - AGES
1 times
South Africa - MCC
1 times
NPRA - Malaysia
4 times
DCGI
13 times