It provides compliance services in GCP, GLP and GMP area for EMA and FDA requirements listed below but not limitted to:
- Auditing all processes contributing to the performance of a clinical trials that they are conducted in accordance with ICH guidelines, GCP and other regulations especially national regarding different therapeutic areas of clinical trials like:
Dermatology, Neurology, Pulmunology, Oncology, Cardiology, Primary Care, Gastrointestinal, Pain Management, Diabetes, Infectious Disease, Medical Experiment, Medical Devices and Biologics (Vaccines, monoclonal antibodies)
- Administrating of all quality system documentation: SOPs, instructions, forms, templates
- Building-up GCP, GMP and GLP Compliant System from scratch including SOPs, Templates, Forms and QA System Management
- Conducting of the following types of audits:
- - Investigator sites
- - Vendors and Contractors
- - Trial Master Files
- - CRO and Archive facilities
- - Investigation of alleged fraud in clinical research
- - Clinical Study Reports
- - System, "Ad Hoc" and "For Cause" Audits
- - Affiliates
- - Regulatory Authorities Inspections Pre-Audits
- - SOPs and Documentation Management / Change Control