It involves identifying areas where companies cannot perform well and underlying root causes and recommending improvement plans (troubleshooting) for those root causes.
Mock GMP Audit
In order to eliminate possible nonconformities before the authority and customer inspections , mock inspections are carried out by expert teams for the medical product manufacturers.
Supplier Audits
It includes the inspecting and reporting activities of the GMP compliance status of the starting material producers by experts on behalf of the medical product manufacturers.
Equipment Evaluation
The URS and GMP requirements of the equipment purchased/ to be purchased by companies are examined, and on-site inspections att end to at their FAT / SAT stage,
Process Development
Rapid and innovative solutions are established by determining the root-causes of the deviations in the production process and as a result, it is aimed to increase in the efficiency and capacity for all production processes.
Feasibility Study of the Facility
The detail of the costs (construction, hardware, electricity, etc.) required for the installation of the facility is calculated by considering the products and capacity determined by the investor, and realistic analysis about the investment is presented.
Design Review
The projects, which have already passed the concept project and detail project planning stages, but need a different professional perspective for the last time, are reviewed in detail by the professionals in the field, and the recommendations, if any, are given for the areas of nonconformity and company development.
Process Gap Analysis 