As an expert of GxP pharmaceutical affair regulation for Europe, the United States and Japan, we support pharmaceutical product development and the factories.
We support a wide range of areas such as GLP, GCP, GMP and management after production and sales; however, provide the services mainly in 2 fields below.
GCP field
- To conduct audits for clinical investigation as well as its medical institutions (Investigator) and contract research organizations (CRO)
- To provide advice of GCP conformity inspection.
GMP field
- Due diligence regarding the GMP regulation for pharmaceutical product factories (Examination・Audit)
- To instruct site improvement including FDA support
We support submission of English reports.
GxP
We provide specialized information regarding pharmaceutical regulations of GMP, GQP, GVP, GLP and GCP for domestic and overseas pharmaceutical companies. Also, we develop quality system and provide QA services of pharmaceutical audit.
Involving in Project
Outsourcing companies may have issues of research and development, establishment of quality control system for overseas companies as well as implementation of computer validation. We support to solve those issues through involving in the projects and individual consulting, etc.
With abundant experiences of research and development, pharmaceutical audit as well as international experiences and knowledge, we are able to participate in a variety of project in the company as an expert. Especially if you have a project under consideration in the field blow, please consult with us.
- Research and Development
- Quality control framework establishment for each sector (for overseas)
- Computer system validation implementation
