The following documents are required, according to each stage in the service:

Phase I (at the Center):

• Application form.

• 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 Contract(s) 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:

• a. Data entry ((tabulation, verification of transcript data, software used).

• b. 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).

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.