Accreditation Certificate of a Clinical Research or Bioequivalence Center

about-the-service

This service allows customers to apply for the accreditation of GCC-approved centers for clinical or bioequivalence studies.

service-process

when-applying-through-the-website

• Log in using UAE PASS to start the service
• Fill out the application form
• Attach the required documents
• Pay the fees
• Submit the application
• Issue the Certificate of Accreditation for Clinical Study Center or Bioequivalence

conditions-and-requirements

• This application should be submitted by the pharmaceutical company or the local agent which contracted with BA/BE center along with letter of authorization.
• The service is not required for bioavailability/bioequivalence centers approved by GCC countries.

required-documents

• The following documents are required, according to each stage in the service:
• Phase I (at the Center):
• Latest inspection report issued by competent authority (if any)
• Notarized Copy of the operating license issued by the competent authority in the country of origin.
• Copy of the Contracts of Leasing of the Clinical Unit and of the Rendering of Services of Laboratory Analysis (if applicable).
• Training schedule for employees.
• Curricula of the main researchers and the persons responsible for the clinical, analytical and statistical stages.
• List of SOP’s , and 5 SOP’s from the above mentioned should be provided.
• Organizational chart of the center and the study plan.
• Background of the Bio equivalence Center (Site, Master file), including total number of studies conducted and list of those submitted to other health authorities.
• Notarized copy of accreditation certificates.
• Clinical Phase:
• Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).
• Staff training schedule.
• List of the equipment and instruments used.
• The following SOPs: collecting samples , emergency care of subjects, hospitalization of subjects, cleaning and preparation of areas for hospitalization of subjects.
• Clinical Laboratory Analysis Stage:
• Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).
• Staff training schedule.
• List of the equipment and instruments used.
• List of technicians in the area with the technical qualifications for each professional.
• Models of the control file / control records used ( temperature of the refrigerators, freezes, room temperature, room humidity, calibration of pipettes, reagents and standards).
• Bio-safety programs.
• Analysis Phase:
• Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).
• Staff training schedule.
• List of the equipment and instruments used.
• List of area technicians with technical qualifications for each professional.
• Models of the control file / control records used ( temperature of the refrigerators, freezes, room temperature, room humidity, calibration of pipettes, reagents and standards).
• Statistics Stage:
• Standards Operation Procedures, contemplating of the following points:
• Data entry ((tabulation, verification of transcript data, software used).
• Data processing and statistical analysis (methods of calculating pharmacokinetic parameter methods to identify factors to define the outliers, variance analysis, confidence interval calculation and program used).
• Proof of contract between the bio-equivalence center and the person in charge of statistics (in case of outsourcing).