Markets
Since 1999, Shiba Biotechnology has been involved globally in addressing client requirements with interpreting and applying evolving biologic and drug regulations. Shiba's team consists of multidisciplinary subject matter experts with experience in USFDA, EMA and JP regulations having enabled drug development process encompassing GXP and ISO requirements inclusive of non-clinical and clinical studies. This integrated approach has provided applicable recommendations to the clients.
Regulatory compliance related services
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.
Quality Management System
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.
Quality Assurance & Quality Control
Our teams enable you to address challenges in quality issues across the GXP platform -GCP, GLP, cGMP – in manufacturing, risk assessment, validation, Standard Operating Procedure preparation and review, labelling, facility design review, training, investigations, corrective and preventive actions and provide in-house QA support, where relevant.
Audits and Regulatory Inspections
With a reputation for demonstrated excellence in GCP, GLP and cGMP interpretation and application of the regulations and guidelines, Shiba Biotechnology offers comprehensive global auditing services which include – due diligence audits, site audits, facility audits, vendor audits; and fraud and misconduct audits. Provide training and support to in-house QA to conduct audits.
Training
Our team is adept at conducting innovative training sessions and workshops in GCP, GLP, and cGMP requirements and compliance. Customized training has added value to personnel whose activities impact regulatory compliance. We have also provided training of cGMPs required at companies operating under FDA's consent decree.
Data Integrity and Good Documentation Practices
We have provided extensive training on the requirements of data integrity and good documentation practices across the GXP platform. Several of our clients have used the SOPs on Data Integrity and Good Documentation Practices we have authored in providing guidance to their personnel in adhering to these requirements. In addition, we have conducted training sessions on Data Integrity and performed audits to ensure there are no DI concerns.
