Pre Clinical Research and Development

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PreClinicalResearchandDevelopment

VeedaClinicalResearchhassetfootinthepreclinicalecosystembyacquiring amajoritystakeinBioneeds(areputedPreclinicalCROwithmorethan12 yearsofexperience).Veedawillnowprovidefullserviceaswellasfunctional serviceinallthestagesofdrugdevelopmenttosupportbiotechand pharmaceuticalcompanies.

WiththeacquisitionofBioneeds,VeedaClinicalResearchnowhasthe capabilitytosupport(bio)pharmaceuticalcompanieswiththeirpreclinical studiestowardsINDandNDAsubmissionofbothoncologyandnon-oncology NCE/NME.TheacquisitionmarksasignificantmomentinVeedaCR’shistory asitacceleratesVeeda’stransformationjourneyanditscommitmenttobe a360-degreeserviceproviderininnovationanddeliveryofnoveldrugs.

Bioneeds-ALeadingPreclinicalContractResearch Organization

 One-stopsolutionforservicesrelatedtopreclinicalstudiesindrugdevelopment

 Richexperienceinconductingpreclinicalstudies

 GLP-certifiedtestfacilityandaccreditedbytheAAALACInternational(The AssociationforAssessmentandAccreditationofLaboratoryAnimalCareInternational)

 Productcharacterization-HPLC(ProA,RP,SE,CE),LC-MS(ORBITRAP)-Intact mass,subunitanalysis,peptidemapping,disulfidebondlocations,glycananalysis cell/ELISAbasedassays,BIACOREbasedassays

 Richexperienceinmedicinalchemistry,customsynthesis,processR&Dandscale-up

Drug Chemistry & Preclinical Services

 Exploratorystudies:Dose-limitingtoxicologystudies&doseescalationtoxicology studies

 INDenablingsafetystudiesacrossmammaliantoxicology,genetictoxicology, DMPK,andbio-analysis

 Impurityqualificationstudies(Profiling,isolation,characterization,certification,and evaluation)

 Toxicokineticanalysis

 Preclinicalbioanalyticalservices(Methoddevelopment&validation)

 Immunogenicitytesting

 Bioassays(Invitro/Invivo)

 Cellbasedpotency&functionalassays

 PortfolioofADMETassaysforNDA/ANDAenablingsafetyevaluations

 Polyclonalandmonoclonalantibodydevelopmentandpurification

 Productcharacterizationandproductreleasetestingforbiopharmaceuticals

 Invitrostudiesthatarealternativetoinvivostudies

 Synthesisofpotentialmetabolites&impuritiesforinitialstudies

Why Veeda?

 VeedaisanindependentindianCROwith16yearsofexperience

 Veedahasconductedover3800+studies&hasworkedwithover200 (Bio)pharmaceuticalcompaniesaroundtheworld

 VeedahasanexemplaryregulatoryrecordofsuccessfullycompletingauditsofUSFDA, AGES,MHRA,ANVISA,WHO,NPA,ANSM,MCC,DCGI&NPRA

 Duetostringentqualitynormsandtransparency atallstages,Veedaisconsideredtobe apreferredpartnerformany(Bio)pharmaceuticalcompanies

 Veedahasavast experienceinscientificandregulatory-compliantprotocoldesigning thatenablesthedrugdevelopmentprocessofEarlytoLatephaseclinicaltrials

 Veedahasover900+analyticalmethods&60+NCEmoleculesdevelopedand validatedsofar

 Veedaensuresstudy-specificclinicalsafetymeasuresforallsubjectsthroughrisk mitigationstrategies

 VeedahasQualityManagementSysteminplacetocaptureanynon-complianceor deviationidentifiedduringthestudywithaneffectivemechanismofcorrectiveand preventiveactionsimplemented

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