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Clinigene International Limited
Established in 2000, Clinigene a fully owned subsidiary of Biocon Limited, is a full-service Contract Research Organization (CRO) providing early-stage as well as late-phase clinical solutions, and central laboratory, immunoanalytical and data management services. Clinigene operates a CAP-accredited Central Lab and GLP-compliant Bioanalytical Laboratory for small and large molecules, and a 104-bed clinical pharmaceutical unit in Bangalore, India. Clinigene’ s early-phase clinic and laboratories have been inspected by EMEA and the US FDA
Company Contact:
Mr. Nageswara Rao
Phone:
+ 91 80 2808 2780
Fax:
+ 91 80 2852 2989
Email:
BD@clinigeneintl.com
Website:
http://www.clinigeneintl.com
Mr. Nageswara RaoPhone:
+ 91 80 2808 2780Fax:
+ 91 80 2852 2989Email:
BD@clinigeneintl.comWebsite:
http://www.clinigeneintl.com- India
ANALYTICAL
BIO-ANALYTICAL
Services
Assays and SuppliesBioassaysCell CultureNeutralizationRadioassaysRadioimmunoassaysTransporterElisa/Western BlotFlow CytometryGeneralCentral LaboratoryClinical ChemistryMethods Development and ValidationMethods Development/ValidationMicrobiologyGMP-GLPBioanalytical GLPPre-GLPImmunoassayImmunochemistryImmunohistochemistryPCR
CLINICAL DEVELOPMENT
Clinical Services Provided
Clinical TrainingData/IT/StatisticsBiostatisticsData ManagementMedical Monitoring/SafetyMedical WritingPost-MarketingProject ManagementProtocol DevelopmentRegulatory/Quality/SafetyElectronic sbmissionsPharmacovigilanceQuality AssuranceRegistries/Observational StudiesRegulatorySafety/PharmacovigilanceSite/Study/InvestigatorInvestigator EducationInvestigator RecruitmentPatient Recruitment/RetentionSite AuditSite ManagementSite SelectionStudy MonitoringStudy Supply Management
Clinical Study Type
Formulations Administered
CONSULTANT
Areas of Expertise
FACILITY REGULATORY STATUS
REGULATORY
Formulation Category
Regulatory Services
General Properties
| Size of the Facilities (square feet) | 65 |
| Number of People | 165 |
Equipment
| Equipment | Check if exist |
|---|---|
| HPLC | |
| LC-MS | |
| GC | |
| NMR | |
| Solid State NMR | |
| DSC | |
| TGA | |
| FTIR | |
| NIR | |
| Raman | |
| UV-Vis | |
| PXRD | |
| Particle Sizer | |
| Karl Fischer |

