Pro-Active Consulting Inc. (PAC)
| Corporate Name | Pro-Active Consulting Inc. |
|---|---|
| Founding | On April 28, 2009 |
| Address | Head Office 7-25 Yayoigaoka, Tosu-shi, Saga 841-0005, Japan TEL：81-942-80-4333 / FAX：81-942-84-0817
Yayoigaoka Office |
| Management Representative | Shigeru Makizaki（Profile） |
| Business Activities | GxP QA Consulting（Pharmaceutical Consultant） Business consulting（Small and Medium sized Enterprise Management Consultant） Translation services（Japanese<->English） |
| Capital Stock | 5 million yen |
Corporate Philosophy
Pro-Active Consulting Inc. (PAC) is an expert in pharmaceutical regulation in Japan, Europe and the United States, and actively supports companies challenging the global expansion of their pharmaceutical and medical device development.
Our philosophy is to contribute to the improvement of public health around the world by providing high-quality consulting services based on our extensive experience and proven track record.
GXP QA Consulting
Pharmaceutical and medical device development (GLP and GCP), Post-marketing control (GMP, GVP/GPSP), Quality Assurance (QA) support and Global development support on FDA in the U.S. and EU-EMA
PAC actively supports companies challenging the global expansion of their pharmaceuticals and medical devices.
- Pro-Active Consulting Inc. (PAC) supports pharmaceutical product development (GLP, GCP) and the factories (GMP) as an expert of GxP pharmaceutical affair regulation (Including cosmetics and medical devices) for Japan, Europe and the United States. PAC provides consulting and auditing services based on the pharmaceutical regulations such as GLP, GCP, GMP and GVP/GPSP, we support building efficient and effective quality management systems (QMS) to companies thinking about Global expansion.
- We conduct audits for medical institutions and contract research organizations (CRO, vendors), and audits of pharmaceutical and medical device factories in compliance with GMP regulations as well as propose building flexible systems in accordance with the size of the companies based on our extensive experience.
- Our philosophy is to contribute to the improvement of public health around the world by providing high-quality consulting services.
Services Under Entrustment
GXP QA (Audit) and Consulting Services
- Support for QMS development for pharmaceuticals and medical device manufacturers
- Preparations for regulatory inspections on GCP, GMP & etc. (including overseas regulatory authorities)
- GCP audit for clinical trials of pharmaceuticals and medical devices
- GCP audits in investigator-initiated clinical trials and clinical research (including preparation of audit procedures)
- GMP audits for plants that handle pharmaceuticals, medical devices, and cosmetic ingredients
- GCLP audits for GLP facilities, Bio-Analytical Laboratory, etc.
- GVP/GPSP external audits and self-inspections for pharmaceuticals and medical devices
Build efficient and effective quality management systems.
Propose the construction of flexible systems according to the company sizes and risks.
