preclinical cro (brochure) · designed to provide glp studies in accordance with testing guidelines...
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BIONEEDS
Outstandingcustomerservicesandcommitmenttoscientificexcellenceandqualitythroughbestinclassservices Conformancetoglobalregulatorynorms(USFDA,EPA,OECD,EEC,MAFF,EMEA,MHRA,ANVISA,DCGI,CIBRC,RCGM) Bestinindustryteamleadsandtalentpoolwithextensiveindustryexperienceanddomainexpertise Worldclassinfrastructurewithcuttingedgetechnology InternationallyacclaimedContractResearchOrganization
MedicalDevicesCosmetics/TopicalDrugs(AlternativestoAnimalStudies)
AgrochemicalsPharmaceuticals
BiopharmaceuticalsNutraceuticals/Herbals VeterinaryDrugs
DrugTesting
BIONEEDSINDIAPRIVATELIMITEDisaBangalorebasedContractResearchOrganization,providingIntegratedDiscovery,Development&RegulatoryServicestoPharmaceutical,Biopharmaceutical,Agrochemical,Industrialchemical,Herbal/Nutraceutical&Medicaldevicecompanies. STATEOFTHEARTFACILITIES Cuttingedgedrugdiscovery&developmentlabstosupportbiology,Invivopharmacology,pharmacokinetics,toxicology,medicinalchemistry,customsynthesis,processR&D,cGMPmanufacturing,formulation&analyticaldevelopmentservices Bestinclassinfrastructureina2,50,000sq.ft.builtupareaequippedwithstateoftheartfacilities Vivariumwith85exclusiveanimalroomsbuiltasperinternationalstandards
NationalGLPComplianceMonitoringAuthority(NGCMA),Dept.ofScienceandTechnology,GovernmentofIndia CommitteeforthePurposeofControlandSupervisionofExperimentsonAnimals(CPCSEA),MinistryofEnvironment,ForestsandClimateChange,GOI. StateDrugControllerasaGovernmentapprovedDrugTestingLaboratoryforcarryingouttestsonDrugs/CosmeticsandRawMaterialsusedinmanufactureonbehalfoflicenseesformanufactureandforsaleofDrugs/Cosmetics ReviewCommitteeonGeneticManipulation(RCGM),departmentofbiotechnology,GOItoconductexperimentsonanimalsforDNAorGeneticallymodifiedresources AssociationforAssessmentandAccreditationofLaboratoryAnimalCare(AAALAC) R&DunitrecognizedbyDepartmentofScientific&IndustrialResearch(DSIR) USFDAauditedlaboratorywithno483 ISO17025AccreditationfromNABL(NationalAccreditationBoardforTestingandCalibrationLaboratories)forBiologicalandChemicalTesting ApprovedbyCIB&RC(CentralInsecticidesBoard&RegistrationCommittee)GovernmentofIndia
INTEGRATEDDISCOVERY,DEVELOPMENTANDREGULATORYSERVICESBIONEEDS COSMETICS/TOPICALDRUGS(ALTERNATIVESTOANIMALSTUDIES)
BIOLOGICS/BIOSIMILARS/BIOPHARMACEUTICALS/VACCINESAGROCHEMICALS/INDUSTRIALCHEMICALS
PHARMACEUTICALS/HERBALS/NUTRACEUTICALS/VETERINARYDRUGS
MEDICALDEVICES
ABOUTUS
ACCREDITATIONS/CERTIFICATIONS
Telephone:+918162214400|Mobileno.:+919844457677
BIONEEDS SERVICES CAPABILITIES / PHARMACEUTICALS HERBALS/ /NUTRACEUTICALSOECDFDAICHScheduleY
VACCINES
Pyrogens Physicochemical Endotoxins AbnormalToxicity Sterility DoseStability EfficacyTest BatchReleaseTest Immunogenicity Toxicology PotencyTesting
ScheduleYJP,OECDWHOIP,BPEP,USP
NewChemicalEntities(NCEs) HeterocyclicBuildingBlocks&Scaffolds ComplexMolecules&Prodrugs KeyRawMaterials,AdvancedIntermediatesetc. Impurities&StableMetabolites– LibrarySynthesis
MedicinalChemistry:
DrugDevelopment: ProcessDevelopment&OptimizationofNCEs FormsSelection MaterialGenerationasRequiredforPreclinical(nonclinical)Studies PhysChemStudies MethodDevelopment&Validation
OrganicVolatileImpurities,ResidualSolventsasperUSP/EP
GenerationofHits&TransformingHitsintoLeads Leadoptimization&SupportforDrugCandidateNomination LibrarySynthesisCustomSynthesis:(Frommgtomultikgscale)
SupportinIdentification&Characterization Preparation/Isolation,Qualification&Supply
ProcessResearch: ExpertiseinQualityProcessResearchforAPIs(ActivePharmaIngredients)&AIs(ActiveIngredients) StabilityStudies
Working/ReferenceStandard–Preparation,Qualification&Supply
QualificationofStandards RouteScouting,NoninfringingProcessDevelopment PatentableNovelProcessDevelopment ProcessImprovementProjects(CostReductionProjects)
ForcedDegradation
DossierPreparation&TechnologyTransferAnalyticalServices: RawMaterialCharacterizationasperlatestPharmacopoeia(USP/BP/EP/IP/JP) MethodDevelopment&ValidationasperICHGuidelines ImpurityProfiling:Methoddevelopment,Identification,Isolation,Characterization QualificationofStandards:Preparation,Characterization&EstablishingMassbyAssay(PotencyDetermination)
CHEMISTRYSERVICES Physicochemical AnalyticalChemistry FiveBatchAnalysis(ImpurityProfile) Toxicology Ecotoxicology GeneticToxicology SixPackToxicityStudies BioassayforBiopesticides REACHServices
AGROCHEMICALS/INDUSTRIAL CHEMICALS
BIOLOGICS BIOSIMILARS/ /BIOPHARMACEUTICALS CustomAssayDevelopmentServices Biologics/Biosimilars/BiopharmaCMCSupportAssays BioanalyticalServices(PK/TK/Immunogenicity/InvitroAssays) FinalProductCharacterization AntibodyProduction,Purification,Labeling&Characterization HostCellContamination Efficacy 1D/2DGelElectrophoresis Toxicology EMEAFDARCGMScheduleY
InvitroDermalPercutaneousAbsorptionStudies/IVPT Invitro3T3NRUPhototoxicityTest InvitroSkinCorrosionTest IsolatedChickenEye(ICE)Test InvitroPhototoxicityTest BovineCornealOpacity&PermeabilityTest(BCOP)
InvitroSkinIrritation&OcularIrritationStudies DirectPeptideReactivityAssay(DPRA) LocalLymphNodeAssay–LLNA(BrdUELISAMethod)
ALTERNATIVESTOANIMALSTUDIESFORTESTINGCOSMETICS,TOPICALDRUGS&CHEMICALSUBSTANCES
OPPTSCIPACCIBRCEPAOECD
InsulinAssays RabbitPyrogenTesting HumanChorionicGonadotropin EstrogenicActivity Follitropin,ResidualLHActivity Erythropoietin(EPO) MenotropinFSH/LHActivity
EndotoxinTesting
TestforHistamine SpecificActivities ImmunogenicityTests(forHIVAntigens,HepatitisAntigensetc) EfficacyofAntimicrobialPreservation AbnormalToxicity SterilityTests TestforMicrobialContamination MicrobiologicalAssayofAntibiotics
BIOASSAYSUSPIPBPEPJP
MEDICAL DEVICES Genotoxicity ImplantationStudies HemocompatibilityTest SkinSensitization Irritation/IntracutaneousReactivity SystemicToxicity Biocompatibility Cytotoxicity BiologicalRiskAssessment
USFDAISO10993ASTM
ADMEPK/Invivo&Invitro ProofofConcept Efficacy Toxicology BatchReleaseTesting PhysicochemicalNumerousStudiesConducted&SuccessfullySubmittedtoDifferentRegulatoryAgencies
IMPURITY QUALIFICATION
Email:bioneeds@bioneeds.in
INHALATIONTOXICOLOGYSERVICES
PhysicalState Odour FlashPoint StorageStability Color Miscibility CorrosionTest Density Viscosity MeltingPoint BoilingPoint Flammability SelfIgnition AutoIgnition
pH PartitionCoefficient ParticleSize Hydrolysis DissociationConstant ThermalStability SurfaceTension Absorption&Desorption Solubility EmulsionStability VaporPressure ExplosiveProperties Oxidizingproperties
PHYSICALCHEMISTRY
ACUTETOXICITYBIOLOGICALTESTS
AntibodyProduction,Purification,Labeling&Characterization Purity SDSPAGE
NeutralizingAntibodyAssays MonoclonalAntibodyProduction FinalProductCharacterization
HostCellDNA&HostCellProtein BiologicalActivity/Potency(Invitro/Invivo/Exvivo) Quantification(Colorimetric/UV280) ProcessRelatedContaminants/ImpurityCarryOverDetermination Endotoxin(Qualitative&Quantitative) pH(Liquidsamples) MycoplasmaDetection/Quantification Biologic/Biosimilar/BiopharmaCMCSupportAssays BioanalyticalServices(PK/TK/Immunogenicity/InvitroAssaysforBiologics/Biosimilars&BiopharmaProducts) CellProliferationAssays
AcuteOral/Dermal/IV/IM/SC/IP/Ocular AcuteInhalation AcuteDermalIrritation/Corrosion AcuteEyeIrritation/Corrosion AcuteInfusionStudies SkinSensitizationbyGPMT
ROUTESOFADMINISTRATION Oral Inhalation Intravenous Ocular Dermal Intradermal Intramuscular Intranasal Intraperitoneal Intraocular Intravitreal Intracorneal Subcutaneous Intratracheal Infusion
IMMUNOTOXICOLOGY LocalLymphNodeAssay ImmunoHistochemistry VaccinePotencyTest ClosedPatchTest
SUBCHRONIC&CHRONICTOXICITY 90DaysRepeatedDoseStudies 180Days&aboveChronicToxicityStudies/CombinedChronic&CarcinogenicityStudies CarcinogenicityStudies NeurotoxicityStudies RepeatedDoseInfusionStudies JuvenileToxicityREPRODUCTION&DEVELOPMENTALTOXICITY PrenatalDevelopmentalToxicity 1/2GenerationReproductionToxicity CombinedReproduction/DevelopmentalToxicity SegI,II&IIIStudies DevelopmentalNeurotoxicity HershbergerBioassay UterotrophicBioassay ExtendedOneGenerationReproductiveToxicityStudyGENETICTOXICITY BacterialReverseMutationTest(AMES) InvitroChromosomeAberrationTest InvivoBoneMarrowChromosomeAberrationTest InvitroMammalianCellMicronucleusTest MammalianGeneMutationTest(HPRT/MouseLymphoma) MammalianErythrocyteMicronucleusTest CometAssay
SUBACUTETOXICITY 7/14DaysDoseRangeFindingStudy 14/28DaysRepeatedDoseStudies
ENDOCRINESCREENING HershbergerBioassay UterotrophicBioassay
EFATE&RESIDUE Residue&Persistence DirectPhotolysis Hydrolysis Carbon/NitrogenTransformation Biodegradability ActivatedSludgeRespirationInhibitionTest AerobicandAnaerobicTransformationinSoil
ECOTOXICITYAquaticEcotoxicology
TerrestrialEcotoxicology
FreshwaterAlga&Cyanobacteria,GrowthInhibitionTest DaphniaAcuteImmobilizationToxicityStudy DaphniaMagnaReproductionTest AcuteFishToxicityStudy Fish,EarlyLifeStageToxicityTest ChironomousAcuteImmobilizationTest MicrobialPesticideTest LemnaToxicityStudy WaterSedimentMyriophyllumSpicatumToxicityTest
LaboratorytestassessmentofplantProtectionProductsinnontargetarthropods CollembolanReproductionTest
AcuteDelayedNeurotoxicityStudies AcuteOralToxicityStudyInHoneybees EarthwormReproductionTest AcuteToxicityStudyInEarthworm AcuteContactToxicityStudyInHoneybees AvianAcuteOralToxicityStudy
Predatorymite(Hypoaspis(Geolaelaps)aculeifer)reproductiontestinsoil
TerrestrialPlantTest:VegetativeVigourTest TerrestrialPlantTest:SeedlingEmergenceandSeedlingGrowthTest SilkWormAcuteToxicityTest TrichogrammaToxicityTest AvianAcuteDietaryToxicityStudy
PRECLINICALSERVICES
Inhalationtoxicologystudiesareperformedforpharmaceutical,agrochemical,chemical&consumerproductsindustries.FacilityisdesignedtoprovideGLPstudiesinaccordancewithtestingguidelinesoftheFDA,EPA&otherregulatoryagencies. Acutestudyforagrochemicals/industrialchemicals(ECB.2.,OECD403,OPPTS870.1300,CIBRC) Repeateddose(28/90days)studiesforpharmaceuticals(ScheduleY) Repeateddose(28/90days)studiesforagrochemicals(OECD412,OECD413) Acutestudyforpharmaceuticals
www.bioneeds.in
ANALYTICALPRECLINICALSERVICES EFateStudies AnalyticalMethodDevelopment&Validation ResidueStudies
PhysicochemicalProperties ActiveIngredientContent(Purity) FiveBatchAnalysis(ImpurityProfile) StorageStabilityStudies AnalyticalServicestoSupportToxicologicalStudies(e.g.,DoseConcentration,Homogeneity,StabilityDetermination)BIOANALYTICAL BioanalyticalServices(PK/TK/Immunogenicity/InvitroAssaysforBiologics/Biosimilars&BiopharmaProducts) CustomAssayDevelopmentServices ClinicalTrialSampleAnalysis HostCellProteinAnalysis(HCP) HostCellDNA(HCD)MICROBIOLOGY TimeKillAssays InvitroAntimicrobialTest PathogenDetection TotalMicrobialCount TotalYeastandMouldCount InvitroMICScreening PreservativeEfficacyTests CATEGORIES
Cosmetics DrugsotherthanthosespecifiedinScheduleC/C﴾1﴿﴾ExcludingHomeopathicDrugs﴿ DrugsSpecifiedinScheduleC&C﴾1﴿MOLECULARBIOLOGY
ProteinProduction&Purification Bacterial,Yeast&MammalianSystem QPCR/RTPCR
EnvironmentalFate
Servicesoffered: AlternatetoAnimalStudies EndocrineDisruptorscreening EcotoxicologyStudies Pathogenicity/Infectivity ResidueAnalysis&FieldStudies ReproductiveToxicity GeneticToxicity Acute6pack&RepeatedDoseAnalyticalMethods,PhysicochemicalTesting,5batchTestingandToxicologicalStudiesEURegistrationsupport PlantProtectionProducts(EURegulation1107/2009) Biocides(BiocidalProductsRegulation528/2012) IndustrialChemicals(REACHRegulation1907/2006)RichExperienceinhandlingActiveIngredientsandFinalProductsTechnicalGrade(Herbicides,Fungicides,Insecticides,Biocidesetc.,)FormulatedProducts(WG/SC/NF/EC/SLetc.,)CombinationInsecticidesBiopesticides
IndependentQualityAssuranceUnit(QAU)ensurescompliancewithinhouseSOPs,GLPandrelatedguidelinesconformingtorespectiveregulatoryspecifications.QAUactivelyreviews/auditsstudyplans,inlifephases,reportandfacility/process.QAUimpartscontinuousinhouseGLPtrainingtostafftoensurehighestqualityadherenceandcompliancetoOECDGLPprinciples.QUALITYASSURANCEUNIT
Email:bioneeds@bioneeds.in
REACHSERVICES
BioneedsIndiaPrivateLimited,Devarahosahally,SompuraHobli,NelamangalaTq,BangaloreRuralDistrict562111,Karnataka,INDIATel:+918162214400GLPAccreditedPreclinicalDevelopmentCenter BioneedsIndiaPrivateLimited,P3,PeenyaIndustrialArea,1stMainRoad,Peenya1stStage,Bangalore560058,Karnataka,INDIATel:+918022658400
Chemistry&BiopharmaFacility
+919844457677bioneeds@bioneeds.in www.bioneeds.in
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