- Contact and communication with Authorities and State Drug Agency
- Development of the main Validation and Qualification documents (GVMP, VMP),
- Qualification protocols, tests (IQ/OQ/PQ) and reports for Technological equipment (sterile and non-sterile processes),
- Qualification protocols, tests (IQ/OQ/PQ) and reports for Clean rooms and HVAC system,
- Qualification protocols, tests (IQ/OQ/PQ) and reports for Clean utilities (purified water, water for injection, clean steam, clean compressed air, etc.),
- Qualification protocols, tests (IQ/OQ/PQ) and reports for Computerized systems,
- Validation protocols, tests (PV) and reports for APS (Aseptic Process Simulation) and MFT (Media Fill Test),
- Qualification protocols, tests (IQ/OQ/PQ) and reports for QC Lab equipment (scales, autoclaves, incubators, isolators and safe cabinets, etc.),
- Qualification protocols, tests (IQ/OQ/PQ) and reports for auxiliary equipment and systems,
- Qualification/validation of warehouses and cold chains (including mapping),
- Support and conducting FAT / SAT (including Protocols/Reports development),
- Validation protocols, tests (PV) and reports for Technological Processes,
- Development of protocols, conducting tests and preparing reports for Cleaning validation.