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Founded in 2004, Clinisindo Laboratories is an independent Contract Research Organization (CRO) dedicated to bioavailability and bioequivalence (BA/BE) study for pharmaceutical companies, located in Jakarta, Indonesia. Our quality system, resources and facilities are managed to meet the regulatory authority requirements and international standard for GCP, GLP and BA/BE study to ensure our study report acceptance in local Drug Regulatory Authority. Accredited and Validated Bioanalytical Methods.

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Richard Stefano

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PT. Novell Pharmaceutical Laboratories

Richard Stefano

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Home | Clinisindo.com | clinisindo.com Reviews

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Founded in 2004, Clinisindo Laboratories is an independent Contract Research Organization (CRO) dedicated to bioavailability and bioequivalence (BA/BE) study for pharmaceutical companies, located in Jakarta, Indonesia. Our quality system, resources and facilities are managed to meet the regulatory authority requirements and international standard for GCP, GLP and BA/BE study to ensure our study report acceptance in local Drug Regulatory Authority. Accredited and Validated Bioanalytical Methods.

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7 clinical facilities

8 bioanalytical facilities

9 statistical facility

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Home | Clinisindo.com | clinisindo.com Reviews

https://clinisindo.com

Founded in 2004, Clinisindo Laboratories is an independent Contract Research Organization (CRO) dedicated to bioavailability and bioequivalence (BA/BE) study for pharmaceutical companies, located in Jakarta, Indonesia. Our quality system, resources and facilities are managed to meet the regulatory authority requirements and international standard for GCP, GLP and BA/BE study to ensure our study report acceptance in local Drug Regulatory Authority. Accredited and Validated Bioanalytical Methods.

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clinisindo.com

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Clinical Facilities | Clinisindo.com

http://www.clinisindo.com/index.php/clinical_facilities

The entire laboratory equipped by alarm and sensor to ensure secure access to and from Clinisindo Laboratories facilities. The facilities located within the PT Clinisindo Laboratories include the following:. Room for screening and monitoring. Wards (separate male and female) with capacity 28 beds. Recreation area with TV, DVD and internet facility. Doctor and nurse station. Canteen and room for dosing. Nurse call in wards. Pharmacy room for storage and dispensing. Ambulance (standby in the study).

2

Bioanalytical Instrument | Clinisindo.com

http://www.clinisindo.com/index.php/bioanalytical_instrument

EquivTest version 2.0 is used to perform statistical analyses of AUC0-t, AUC0-∞, Cmax using analysis of variance (ANOVA) after transformation of the data to logarithmic (ln)-values. Jl Ulujami Raya No.12, Pesanggrahan. Phone : 62 21 73889918. Fax : 62 21 73885453.

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Service | Clinisindo.com

http://www.clinisindo.com/index.php/service

Protocol and Study Design. Case Report Form Design. Independent Ethics Committee Submission. Recruitment and screening of subjects. Developments and validation of analysis methods of drugs in biological matrices. Drug analysis in biological matrices. Biostatistics and pharmacokinetic modeling and reporting. Additional data after regulatory submission. Jl Ulujami Raya No.12, Pesanggrahan. Phone : 62 21 73889918. Fax : 62 21 73885453.

4

About Us | Clinisindo.com

http://www.clinisindo.com/index.php/about_us

To serve a high quality bioequivalence/bioavailability studies with true scientific spirit and compliance with international guidelines on Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). Clinisindo Laboratories is also committed to provide International Standards at Indonesian price. We continuously ensure compliance to GLP and GCP guideline and other official rules and regulations. Approved by United Arab Emirates Ministry of Health in Nov 2013. Quality and Ethics References. Guideline ...

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Laboratories Facilities | Clinisindo.com

http://www.clinisindo.com/index.php/labs_facilities

The entire laboratory equipped by alarm and sensor to ensure secure access to and from Clinisindo Laboratories facilities. The facilities located within the PT Clinisindo Laboratories include the following:. Evaporation and fume hood cabinet. Which equipped with :. Shimadzu Prominence LC-20AD coupled with API 3200 MS/MS system. Shimadzu LC-10AT coupled with Shimadzu SPD-10A ultraviolet detector and Shimadzu RF-10A fluorescence detector. Jl Ulujami Raya No.12, Pesanggrahan. Phone : 62 21 73889918.

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Home | Clinisindo.com

Founded in 2004, Clinisindo Laboratories is an independent Contract Research Organization (CRO) dedicated to bioavailability and bioequivalence (BA/BE) study for pharmaceutical companies, located in Jakarta, Indonesia. Our quality system, resources and facilities are managed to meet the regulatory authority requirements and international standard for GCP, GLP and BA/BE study to ensure our study report acceptance in local Drug Regulatory Authority. Accredited and Validated Bioanalytical Methods.

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