- GRC is a contract research organization committed to exceeding the needs and expectations of our clients by providing innovative, professional, and superior quality service, with integrity, professionalism, and reliability.
- Become the most reliable and service oriented CRO.
- Ensure compliance with the evolving updating regulatory Guidelines.
- Recognize the value of our clients, subjects and employee’s partnership.
- Ensure absolute safety of our subjects.
- Exceed client’s needs through a combination of dedication, hard work and perseverance without.
Our Quality Assurance ensures that Bioavailability/Bioequivalence study is performed in compliance with the general regulatory requirements and international standards for Bioavailability/Bioequivalence study that covers the clinical and analytical aspects.
QA In Clinical Aspect
Our SOPs related to the clinical activity comply with Good Clinical Practice (GCP), the international standard for clinical trials (EMEA & US-FDA).
QA In Analytical Aspect
To obtain reliable results in Bioavailability/Bioequivalence Study, the bioanalytical techniques conducted in GRC are accredited by ISO/IEC 17025:2005 and apply Good Laboratory Practice (GLP) requirements. In developing bioanalytical method validation and procedures, GRC adopted the “Guidance for Industry Bioanalytical Method Validation” from US FDA and EMEA.
Our own SOPs ensure that our procedures, systems, and associated documentation and controls comply with regulatory GCP and GLP guidelines and industry standards.
Our QA role extends beyond auditing to provide education and training of the GRC staff.
Server computer systems are subject to daily, monthly, and yearly system back-ups to assure the safety of all data systems in addition to NAS (Network Attached Server) back-up.
Information system has been designed to meet the regulatory requirements to be used in Clinical Trials.
Complete Business Continuity Plan (BCP) and Data Recovery Plan (DRP), including many daily chores such as Project Management, System back-ups, and Help Desk, and all activities performed daily to maintain service, consistency, and recoverability.
Our data entry is facilitated and controlled through our intra-net which is regulated by security levels.
All our computer systems are protected using adequate anti-virus software.
- S. Food and Drug Administration
- FDA Individual Product Bioequivalence Recommendations
- Dissolution Methods for Drug Products
- International guidelines
- Stability testing of active pharmaceutical ingredients and finished pharmaceutical products-WHO
- Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products