Pro-Active Consulting Inc(PAC) is providing GxP QA consulting service mainly in the area of GCP (Clinical trials) and GMP (Drug Manufacturing) auditing service. Detailed services and profile are as follows;
GxP QA Consulting
As a Quality Assurance Specialist endorsed by long term experience for years in the pharmaceutical industries, we are able to provide wide area of consulting services of Drug Development (GLP, GCP), Drug Manufacturing (GMP) and Pharmacovigilance in relating to the regulation of EU, U.S.A and Japan.
Currently we are providing the service of following two area
GCP area
- Investigators site audit
- Contract Research Organization (CRO) audit
- Advice for conformity audit
- Advice for clinical development in Japan
GMP area
- Due diligence of Drug Manufacturing facilities and Company capability
- Compliance support, improvement support of Manufacturing facilities
Other area of GxPs, GLP and Pharmacovililance
Other GxP audit or consulting services are also able to provide if the client have some problem or request.
* Reports can be provided in English or Japanese.
Contact Information
Shigeru Makizaki
GxP QA Consultant
Pro-Active Consulting Inc, (P.A.C.)
6-360 Yayoigaoka, Tosu, Saga 841-0005 Japan
Tel +81-942-80-4333 / Fax +81-942-84-0817
Mobile +81-90-7928-2880 / E-mail : makizaki_s@pacjp.com
Curriculum vitae(August 17, 2011)
| Name | Shigeru Makizaki |
| Birth Date | May 27th 1963 |
| Home & Office | 6-360 Yayoigaoka Tosu-shi, Saga-ken, 841-0005 Japan |
| TEL | 0942-80-4333 or 0942-84-0817 |
| FAX | 0942-84-0817 |
| makizaki_s@pacjp.com |
| Qualification | |
| Registered Management Consultant M.E.T.I | |
| Education | |
| 1987 | Graduated Industrial Chemistry Miyazaki University |
| Job History | |
| 1987~ | Hisamitsu Pharmaceutical Co. inc.(Hisamitsu Pharm) |
| ~1995 | Research Division |
| ~1997 | R&D Planning and Licensing |
| ~Mar 2009 | Quality Assurance (GCP, GLP, IMP: Investigational Drug) |
| Jun 1997～ | Auditor for GLP and GCP at Hisamitsu Pharm. |
| 1999～ | Auditor for Investigational Drug GMP |
| 2004～ | Auditor for Pharmacovigilance system |
| Feb 2006～ | Manager for Quality Assurance Department at Hisamitsu Pharm |
| April 2009 | Proactive Consulting Inc (Foundation) President |
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<GMP Audit Experience> Auditing Experience: Other GMP Experience |
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<GCP Audit Experience> Auditing Experience: International Experience |
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| <Other History> | |
| 1998～ | Member of JSQA(Japan Society of Quality Assurance) Member of Both Division(GLP and GCP) |
| 2000～ | Member of International Affairs Committee JSQA |
| 2010～ | Member of International Affairs Committee JSQA August 2006 ～ 2009 |
| August 2006～2009 |
Chairman of International Affairs Committee JSQA Editorial Board of QA Journal |
| 2007～2009 | Member of PDA Japan |
| April 2007 | Registered Management Consultant Ministry Economy, Trade and Industry |
| 2010 Feb～ | Active member of SQA Japanese Liaison of International Relation Committee |
| Research and Report | |
| 2000 | Translation of Compliance Program Guidance Manual on GLP Investigation (JSQA GLP Division) |
| 2002 | Use of Clinical Trial Data Conducted at outside of Japan Preparation of CRO Checklist etc. (JSQA GCP Division) |
| 2002 | Audit of Common Technical Document (JSQA GCP Division) |
| 2004 | GCP Computer Validation (JSQA GCP Division) |
| 2006 | Point of Concern about Self-Inspection on Pharmacovigilance |
| 2008 | Point of Concern about Self-Inspection on Good Quality Practice |
| 2009 | Global Guideline for GCP Audit (JSQA GCP Division) |
| 2010 | Consulting on Vocational Training Center |
| Consulting | |
| 2008～2010 | Vocational Training Center |
| 2008～2009 | HACCP System Preparation |
| 2010～ | Preparation PMDA GCP Conformity Audit |
| 2009 | Point of Concern on GCP Auditing (Tokyo) |
| 2009.12, 2010.09 | Start up on GxP Auditing Work (Tokyo) |
| 2009 | Preparation of Business Plan and Marketing (many) |
| Active Area | |
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