Syntiro has successfully delivered several small and larger projects
Provide project QA team for large green field construction project.
Design, construction and qualification including successful acquiring of GMP production license, of a Cell Therapy manufacturing facility.
Qualification of a solids manufacturing facility.
Set-up quality system for API manufacturer, qualification of facility and processes for GMP manufacturing; prepare for client and regulatory audits.
Qualification of CMO for packaging.
Design and qualification of veterinary manufacturing facility for sterile products.
Audit for investment company.
White paper writing for Microbiological aspect of API manufacturing.
Qualification of plant automation systems.
Transport validation of sterile, cold stored products.
Set-up outsourcing of microbiological testing.
GMP GAP analysis for a continuously manufacturing facility solid products.
Set-up of Quality System for Transport Company; training of personnel and support client audit.
Organize training courses for general GMP and GDP.