As Quality Management Systems have to evolve with the evolving regulatory and compliance requirements during drug development, we offer a phased approach to implement cGMP requirements. Seasoned compliance consultants at Shiba Biotech enable organizations to effectively strategize and address the requirements via gap analysis. We enable early stage development companies to establish quality systems to operate in compliance with US FDA regulations and guidelines for the requirements and the production and control of clinical supplies manufacturing. Our teams enable you to address challenges in quality issues – be it in manufacturing, risk assessment, validation, Standard Operating Procedure preparation and review, clinical supplies labelling, GXP training, process investigations, corrective and preventive actions and OOS reviews.