Bioequivalence Center

MSA University - Pharmacy Bioequivalence Center

1. Introduction:

- The newly established Bioequivalence (BE) Center at MSA University is the first nationally recognized licensed BE Center at an Egyptian private university. - The Center is established and being administrated by a team of highly skilled scientists and staff from faculty of pharmacy, in addition to several nationalities well-known consultants. - The BE center is based on many years of academic experience and deep understanding of quality system which has been internationally acknowledged. - The center provides excellent and compassionate care to every volunteer through modern state of the art clinics, accommodating facilities and highly trained, dedicated staff while maintaining strict compliance with the top clinical practice.

2. Mission:

  • Become global service oriented CRO (Contract Research Organization) in the pharmaceutical field.
  • Deliver fast top quality data, at competitive prices.
  • Ensure absolute comfort and safety of our citizens.
  • 3. Quality Policy:

  • We seek to meet and exceed expectations on the basis of quality international top clinical practices.
  • Our team is experienced and well trained.
  • Our in house S.O.P.s are developed to ensure that our procedures, system, and associated documentation and controls comply with regulatory MOPH guidelines.
  • 4. Organization:

    • General Manager: Dr. Dina Wahba.
    • Technical Manager: Dr. May Amin.
    • Quality Assurance Manager: Ch. Ayatollah Mohamed Badr.
    • Clinical Investigator: Dr. Abdel Wahab Mohamed.
    • Study Coordinator: Dr. Asmaa Elrayess.
    • Chief Analyst.
    • Analysis Staff: Dr. Ahmed Yehia.
    • Administration Staff.

    Physician: MSA BE Center has a Physician (Internal medicine), who is specialized for physical examination of the volunteers, observing them during taking the samples and also observes any side effects or adverse events.
    Nurse: specialized for sampling and plasma separation.
    Technician: help nurse to perform their work.
    Study Coordinator: prepare randomization plan and supervise the process of study coding.
    Cleaning Staff: keeping place clean and healthy.

    5. Facilities:

    1. Reception
    2. Administration Room
    3. Archiving Room
    4. Drug Samples Store
    5. Chemical Store
    6. Staff Dining Room
    7. Staff W.Cs
    8. Instrumental Lab.
    9. Data Processing Room
    10. Preparation Lab.
    11. Subject Housing Room: provided with 40 beds and 40 lockers for volunteers.
    12. Samples withdrawal Room: well equipped for sampling withdrawal with centrifuge and deep freezer (-80◦ C).
    13. Physician Room: well-equipped physician room with examination bed and blood pressure monitor. All first aid medications are kept in the first aid locker and oxygen cylinder.
    14. Volunteer Dining Room: full facilities to prepare study meals.
    15. Volunteer W.Cs.

    6. Services:

    1. Bioequivalence & Bioavailability studies
    2. Bio-analytical services
    3. Method development from scratches
    4. Fine tuning of existing methods
    5. Method validation according to validation protocol
    6. Bio-waiver and comparative in-vitro dissolution studies
    7. Formation studies
    8. Training service
    9. Research projects