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Catalog of Services

Our range of products include Analysis Pipelines, Data Mining And Custom Curation Services, Exploratory Toxicology, Custom Synthesis Service, Regulatory Affairs Services and Absorption/Distribution Assays.

Analysis Pipelines
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Analysis Pipelines

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GVK Biosciences offers a wide range of tailor-made NGS data analysis solutions with standard methods and algorithms. The custom made workflow can assess run quality and coverage of various sequencing reads, assemble and map reads to sequences, generate statitics for experiments, perform de novo assembly of sequences. It can also be used to identify variations such as SNPs, SNVs, INDELS and CNVs.

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Data Mining And Custom Curation Services
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Clinical  Pharmacology Data
Objective: To collect all relevant information from the competitive landscape that may be informative in understanding the study outcome from a modeling perspective
Data Sources: The primary data sources are controlled clinical trials published in Medline, PubMed and SBA/NDA reports.

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Exploratory Toxicology
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Exploratory Toxicology

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GVK BIO offers the following preclinical toxicity studies in rodents, complying with national and international guidelines.
  • Maximum tolerated dose study in rodents
  • Acute/Sub-acute toxicity study (Rats, Mice, Guinea pigs)
  • Target organ toxicity
  • Toxicokinetics
  • 7 to 14 day repeated dose study
  • Necropsy and histopathology

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Custom Synthesis Service
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Custom Synthesis Service

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Our well-trained and experienced Chemists have a proven track record for delivering custom synthesis projects, including reference standards, analogues and specially designed lead molecules, with quantity and purity as per client requirements. We have an in-house reagent synthesis group and virtual building block libraries to custom synthesize Scaffolds, Building Blocks and Intermediates.
Synthetic capabilities
  • Building Blocks
  • Scaffolds, Intermediates
  • Reference/Standard Compounds
  • Small Molecules/Analogues for Lead Generation/Lead Optimization
  • Focused Libraries: 50-200 compounds per scaffold

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Regulatory Affairs Services
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Our Regulatory Affairs Team offers seamless expert regulatory advice on pharmaceuticals, biotech and medical devices. The most optimal approach to be taken is determined only after an in-depth understanding of the project, strategic review of the applicable regulatory requirements, timeline planning and stringent execution of regulatory filings, agency contacts and regulation compliance. Experts from other departments also assist the Regulatory Affairs Team, thus forming a complete Clinical Development Group,in order to ensure successful product registration.
Services
Dossier Compilation and Regulatory Submissions
The Regulatory Team has the required skill-set in preparing and compiling dossiers, and submitting clinical trial applications.
Regulatory Agency Interactions
Our team is trained to work closely with the sponsor’s project team, to provide Regulatory Services and to work as an authorized communications agent for the Sponsor.
Regulatory Support
Our team has experts who are well-versed in the discipline. They are subject matter experts who are with the capability to offer support in all the phases of clinical Drug Development – right from the creation of a new IND or IDE to post-marketing support, maintenance and compliance.

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Absorption/Distribution Assays
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  • PAMPA (GI/BBB)    
  • Caco-2 (unidirectional/bidirectional)
  • Efflux transporters – Pgp/BCRP
  • Protein binding (ultrafiltration and equilibrium dialysis)
  • Tissue permeability studies – Franz Diffusion Assay
  • Blood/Plasma partitioning ratio

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Custom Synthesis Chemical
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Synthesis of organic molecules involves diverse chemistry. Some of the reactions  carried out by our custom synthesis unit at gram to kilogram scale include:
  • Process Development
  • Route Optimization
  • Manufacturing
  • Validations
  • Impurities – identification, characterization and synthesis
  • GMP Manufacturing
  • Data supporting CMC Filings

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Enzymes
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Enzymes

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Increasingly, enzymes are being recognized as potential drug targets in Drug Discovery. At GVK BIO, we offer assays for several Enzyme classes using different readouts like fluorescence, luminescence, HTRF, time-resolved fluorescence and radiometry. We also have capabilities to develop and validate client specific customized Enzyme assays.

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High Throughput Screening
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GVK BIO offers High Throughput Screening (HTS) for biochemical and cell-based assays, against numerous target classes such as GPCR, Ion Channel, Transporters and Enzymes. We can execute HTS on assay panels developed in-house, supplied by clients or de-novo assays for a novel target.
The HTS facility at GVK BIO can process more than 30,000 data points in a single day and is suited for both mammalian cell-based and biochemical assays in 96 and 384 well formats. These campaigns help identify several hit molecules. We screen client-provided compounds or vendor libraries, by facilitating access to vendor libraries.
Infrastructure
  • Liquid handlers (Biomek FX with 384 well and 96 well head)
  • Biomek NX with 8 channel head for compound dilution and cherry picking
  • Cytomat integrated with liquid handler that can process up to 170 plates at a time
  • Integrated temperature controlled workstations (-40oC to 200oC) in liquid handlers
  • Multimode readers (BMG Polarstar, ENVISION, Spectramax, etc.)
  • Scintillation counters (Topcount, Micro Beta)
  • Rapid stacks for flexible integrations
  • Reagent dispensers (Multidrop Combi, Flexdrop, Microfill)
  • FLIPR
  • AKTA Explorer  
  • Molecular Biology labs
  • Microbiology labs
  • Insect and mammalian cell culture facilities
  • Scale-up up to 20 liters using wave bioreactor

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Specialized Cell-Based Assays
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Cellular Assays are one of the prime screening technologies used in pre-clinical Drug Discovery process, starting from primary screening to in vitro toxicology. GVK BIO’s focus is on developing relevant, accurate and informative cell-based systems that can simulate in vivo conditions.
The following assays are standardized at GVK BIO, representing our in-house capabilities and infrastructure for conducting cell based assays.
Cytokine assays using fresh PBMCs
  • TNF-α secretion
  • IL-1β secretion
  • IL-6 secretion
Cell proliferation (3H-Thymidine incorporation/XTT/MTT/Alamar blue)
  • PDGF stimulated
  • Serum stimulated
  • PHA stimulated
Cytotoxicity
  • XTT/MTT/Alamar blue
  • Adhesion assays
  • ICAM-1
  • VCAM-1
Cyclooxygenases using whole blood assays
  • COX-1
  • COX-2

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Molecular Biology
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Molecular Biology

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At GVK BIO, we are adept at cloning the gene of interest into choice of expression vector, right from cDNA synthesis. We have extensive experience in site directed mutagenesis/truncated/fusion protein construction.
We routinely use RT-PCR for cDNA synthesis from isolated RNA and also construct cDNA libraries. The cDNA is cloned into expression vectors and the confirmed clone is sequenced using primers for every 250-300 base pairs. We employ various strategies like Gateway, TOPO, Tet-on/off, fusion and tag constructs, based on the client’s requirement.
We also perform mini to giga scale preparation for DNA isolation. The isolated DNA is subject to several quality control checks, Agarose gel electrophoresis, restriction digestion, endotoxin testing and DNA sequencing using primers for every 250-300 base pairs.

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NGS Capabilities Data Analysis
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Next Generation Data Analysis
GVK Biosciences offers a wide range of NGS analysis solutions for the vast amount of NGS data being generated to keep pace with the steepincrease in the productivity of sequencing technologies due to a sharp decline in the sequencing costs.
  • Whole Genome Resequencing: Quality filteration, Variation detection(SNPs, SNVs, INDELS, Structural variations), Mapping reads and Alignment, Functional annotation
  • Transcriptome Analysis: Quality filteration, Identification of novel isoform, novel transcribed regions, fusion genes, alternative splice events, differential expression analysis, Expressed SNVs
  • Small RNA Analysis: Quality filteration, Mapping reads, Expression profiling and annotation of miRNA and siRNA
  • De novo Assembly: Quality filteration, Asembling contigs and scaffolds, Novel and known transcripts identification, Gene predictions and annotations, Pathway analysis
  • ChIP-Seq Analysis: Quality filteration, Peak detection, DNA- protein interaction analysis, DNA Methylation, Histone modification and Motif discovery
  • Exome Analysis: Identification of known and novel SNPs, INDELS and CNVs.

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Nucleosides
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Nucleosides

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Capabilities
  • Synthesis of Nucleoside Building Blocks
  • Coupling and modification of both sugar moiety and base
  • Nucleoside Analogs
  • Heterocyclic Nucleosides
  • Bicyclic and Tricyclic Nucleosides
  • Acyclic Nucleosides
  • Nucleoside Phosphonate Esters

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PK and Statistical Services
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Our PK and Statistical team has extensive experience in the application of pharmacokinetic and statistical principles for varied regulatory submissions across the world. This team carries out:
Estimation of subject sample size and design of study
Development of statistical analysis plans
Randomization according to the study design
Statistical analysis depending on the type of the study
Areas of Expertise
The services offered include, Bioequivalence Analysis, Bioavailability Analysis, PK/PD Analysis and Dose Proportionality Analysis.
Infrastructure
The infrastructure used by this division includes WinNonlin 5.2.1 for PK analysis and SAS 9.1.3 for Statistical Analysis.

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Report Writing Services
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Report Writing Services

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We offer Report Writing Services at GVK BIO, in accordance with ICH E3 guidelines, for various regulatory submissions worldwide. This service is offered as a part of the studies conducted by us, as well as on standalone basis. While the execution of reports is based on a standardized template developed to serve various regulatory submissions, we also adapt or customize the format as per Sponsor mandates.
This team, trained and updated on ICH E3 guidelines, is responsible for the execution of reports in CTD, e CTD, NeeS and ANVISA formats. We also have the capability and provide e-CRF as a client specific requirement.

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Standalone Databases
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Standalone Databases

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Informatics offers a number of target centric and compound centric databases on a standalone basis.   we provide database content to customers where they have an opportunity to integrate the data into their internal tools and databases.
medicinal chemistry database:  a compilation of data captured from more than 120 medicinal chemistry related journals since 1959
target class based compound database:  data is captured and binned based on different class of protein families such as kinases, gpcrs etc.
drug database:  this database covers data on clinical studies, metabolism, adverse events, adme and biological activity for “known drugs” with synonyms
clinical candidate database:  this includes data on pharmacology, adme, phase details and biological activity for “compounds in different clinical phases”
mechanism-based toxicity database:  it comprises toxicity related data and biological activity for drug like compounds or its metabolites with mechanism of action.

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In-Silico Based Drug Repurposing
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GVKBIO offers unique solutions to rescue investments and create new assets thereby strengthening the drug development pipeline in line with clients business and commercial interests. The repurposing activity may be initiated using drug or target or disease.

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ADME
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ADME

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ADME studies help in the optimization of pharmacokinetic characteristics of a drug candidate, identification of the metabolic pathways and provision of valuable inputs for the design of in vivo studies. We offer cost-efficient standardized and customized assays as per the client’s requirement for ADME parameters. Our ADME capabilities include:
  • Physicochemical Studies
  • Absorption/Distribution Assays
  • Metabolism
  • Bioanalysis

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