Shiba Biotechnology provides a high-level consortium of services in quality / regulatory compliance where the projects included conducting due diligence audits / mock -pre-approval inspections (PAI) to evaluate and support, US FDA, WHO, HPB, SwissMedic, and EMA inspections; provide regulatory compliance support with draft responses to US FDA’s 483 observations and Warning Letters to pharmaceutical companies in Europe, India and USA. In addition, assist companies with facility / business due-diligence review for product licensing / acquisition. Act as liaison between the regulatory agency (FDA, EMA, HPB, etc.) and the sponsor.