Mesned Quality Assurance and Compliance is responsible for implementing procedures governing the ethics and integrity within the organization. Ensures compliance with regulatory requirements and international standards throughout all phases of drug development.
With integrity processes developed over 14+ years, Quality and Compliance can tailor our services to deliver the most efficient and cost-effective approach to the projects. We bring professional expertise and complimentary skill sets, to ensure the highest quality data achievable by providing accountability and traceability while emphasizing a total quality and compliance management process. We apply high quality and compliance oversight to our own operations in all our activities, include, Regulatory Affairs, Clinical Research , GMP , Pharmacovigilance and Training.
The Quality Assurance and compliance provides thorough coverage for our clients’ compliance oversight by providing practical application of the local and international regulations and guidance’s.
Our experienced staff offers a comprehensive Quality Assurance and compliance service programs including:
- Evaluation and auditing of GCP, and GLP Quality Processes
- Monitor Assessment Program
- Clinical database evaluation, source verification as well as clinical and statistical reports evaluation.
- GMP compliance program, support the products quality and potency , the analytical stability and release of products.
- Pharmacovigilance and drug safety
- Computerized System Validation to ensure compliance with 21CFR Part 11 “Electronic Records, and Electronic Signatures