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Introduction of consultants
Our Team
Our consultants have worked on drug formulation research
and development, prepared applications for new drugs to the FDA
and similar bodies, worked in market development, GXP services
and engineering service related to construction of pharmaceutical
facilities in Japan and elsewhere.
We have established an extensive network between Japan
and other countries, which helps ensure that we are able to
provide the most effective way to solve problems.
Mr. Sansei OKA, BSc
Mr Oka has a wide range of experience such as formulation science technology,
clinical supply management, regulatory affairs, marketing and sales, in
both research-based pharmaceutical companies and excipient suppliers. He
also has a wide range of personal contacts within the pharmaceutical industry,
academia and relevant authorities, in both domestic and overseas locations.
He is also one of the founders of IPE Inc. and representative director
& partner.
Major achievement; Submission of class 3 medical device, delegates of overseas CDMOs and pharmaceutical companies,
overseas consultant for domestic companies in term of CMC.
Member ship; J- DDS, APST-J, Forum for Pharmaceutical Technology, SRSM and AAPS
Mr. Akio HAYASHI, Msc.
Mr Hayashi has 30 years of engineering experience and has been involved in projects in Japan and overseas.
He established the pharmaceutical engineering division in his previous company (a large Japanese engineering contractor)
and participated in acquisition of pharmaceutical engineering department of the Japanese engineering company
for growth of pharmaceutical engineering business.
He has 20 years of experience in pharmaceutical engineering projects in
Ireland and is familiar with FDA and EDQM GMP and also contract services.
Now, he is a representative director & partner of IPE and is also one
of the founders of IPE Inc.
Recent major achievement; Preparation and support for FDA and EMA inspection in Japan, Preparation and support for NPA/FDA
inspection for dietary supplement manufacturing facilities, Support for Japanese API manufacturers for developing the overseas market
based on the GMP concept, Support for onerseas manufacturer for developing the Japanese market, Poject management
consultant for large scal API manufacturing project., Many experiences of GMP Mock Audit based on FDA and EU GMP.
Mr. Toru ASAKAWA, Bsc.
Mr. Asakawa has more than 25 years of medical device manufacturing experience and his wide range of expertise covers from manufacturing processes
to quality assurance/control and regulatory compliance management. During his career, he has been responsible for production and also carried out
development, application of newly developed devices, complaint and recall management, and coordination work with MHLW, PMDA,
local authorities and third party inspectorate. He was also project manager for obtaining an ISO certificate in 1992 and provided consultancy
to affiliate companies to establish and improve their quality systems. He also has deep experience and knowledge in the area of Japanese, UK, US
and Chinese regulations. These 2 years, he concentrates to work for Chinese medical device regulatory affair and making deep communication with CFDA
for the “Type Test”, ”YZB Standard” and others.
Mr. Keiji OZAWA, Bsc.
Mr. Ozawa has 30 years of experience of pharmaceutical development and
also operation of production facilities. This has included formulation
development, production methodology, specification & testing methodology,
stability testing and the bio-equivalency test for the formulations. He
also has experiences of scale-up studies for pharmaceutical manufacturing
and production method validations, as chairman of the validation committee.
He has 8 years experience as plant manager of a pharmaceutical plant. During
this period, he was the award winner of the SOLVAY INNOVATION PIONEER AWARD.
After retirement, he joined European based pharmaceutical company in Japan as GQP/QA manager for three years. Recent year,
he made GMP consultation work for the Chinese pharmaceutical company in Jiangsu Lianyungang of China.
Mr. Hiroto MIYAMOTO, Bsc.
Graduated agricultural chemistry of Kyusyu University and joined Japanese
major chemical industry: Asahi-kasei. Engaged to food and pharmaceutical
excipient business for more than 30 years, as a manager of R&D, plant
manager and general manger of regulatory affairs of the division until
2007. He was also affiliated with International Pharmaceutical Excipients
Council of Japan (IPEC JAPN), chaired the international harmonization committee,
GMP committee and standards committee of IPEC JAPN until 2007. Also was
belonged to the pharmaceutical excipients committee of Pharmaceuticals
and Medical Devices Agency (PMDA): a branch committee of the Japanese pharmacopoeia
investigation committee of Ministry of Health, Labor and Welfare (MHWL),
supporting to revise Japanese pharmacopoeia due to the international harmonization
of excipients.
He was also experienced market research as a general manager of Asahi-kasei Asia:
A subsidiary of Asahi-kasei in Singapore, from 1996 to 1999.
Mr. Takayuki SUGIMOTO, Bsc.
Mr. Sugimoto has over 40 years experience of IT related business in the
pharmaceutical business, since he joined Eisai in1970. He has in depth
work-related skills in developing, implementing and supporting the operation
of Marketing, R&D and Production management systems. In recent years,
he moved to production filed and he also has been involved in establishing
and implementing ERP(SAP R/3), MES(HITPHAMS, PQDAMS), Automated Warehouse
and Transportation systems with Computerized System Validation (CSV). He
executed the in-house production and quality control management system
CSV in Year 2000, and since then has been engaged in a full range of related
services, with hands on involvement. Through his career, he has built up
familiarity with EU, US and Japanese regulations. He retired Eisai and
been concentrated to consult for CSV since October, 2011. He is a member
of the ISPE GAMP Japan Forum since its inauguration.
Dr. Anri MORIKAWA.
Anri joined a chemical company in 1977 after graduated from master course.
He has experienced synthesis of screening compounds, combinatorial chemistry, and process chemistry for 25 years.
He got Ph. D. degree in 1991. He has been a leader of a project with a US venture company for 4 years from 1997.
From 2002 he has worked as the plant general manager of an API plant in Nobeoka for ten years.
In Nobeoka, he experienced inspections of US, Italian, Australian and Korean authorities.
He has a wide variety of experiences in the field of API from small scale screening compound synthesis to commercial
plant scale production. He made lectures on general chemistry and bio-organic chemistry at Kyushu University of Health
and Welfare in Nobeoka from 2009 to 2012.
He retired the chemical company in the end of Feburuary 2013, and started to work as a freelance consultant.
Mr. Bob Adamson
Bob has over 40 years experience in the pharmaceutical industry. He has substantial experience
in compliance and qualification services and has been actively involved in:
- development of the ISPE Baseline Guide Vol 5 for Commissioning and Qualification,
- development of the ASTM E2500 standard on risk based approaches
- Is ISPE’s project manager for the delivery of Baseline Guide 12 for the Implementation
of Risk Based Approaches to show that facilities and equipment are suitable and fit for intended purpose
Bob has substantial experience of:
- Validation planning and Master Plans
- Impact assessment ( application baseline Guide 5)
- Good engineering Practices
- Design Reviews
- Facility and Equipment audits to EU and FDA
- Quality Risk Management (facility and equipment)
- Change management
He has gained his experience through his work with Foster Wheeler as Manager
for Validation and Compliance services at Foster Wheeler's Office in Reading UK,
12 years with Glaxo in Research and Development, 10 years with Beecham
in production management (both now GSK).
Bob is an active member of the ISPE and is Chair of the UK Affiliate. He
has just stood down from the position as Co-Chair of the Commissioning
and Qualification Community of Practice He is a training course leader
for ISPE on C &Q and ICH Q7, was a member of the ISPE task team that
prepared ASTM E2500. He is both a Fellow of the Royal Society of Chemistry
Chemist and Chartered Chemical Engineer.
Dr. Carey B. Bottom （USA)
Dr. Carey is an experienced leader with a broad background in pharmaceutical analysis,
formulation development, preclinical studies, compound development, quality control,
regulatory affairs, business development and corporate management. He has a successful
history in project and people management and a proven ability to integrate and manage
for success across disciplines.
Dr. David Jordan (Ph , B Pharm, MRPharmS)
Dr Jordan has 30 years of pharmaceuticals-related experience
and has carried out market development work with GSK,
Hoechst Marison, Roussel, Boots, Quintiles and others.
He has worked with the development teams of Sectral (Aventis),
Zantac 300 (GSK), Ventadisk (GSK) and Lasoride (Aventis),
and was involved in their development.
He established White Rose Consulting Ltd and now works as a consultant.
The company provides services ranging from research and development
to market surveys and market cultivation.
Mr. Paul Blunnie
CAREER OBJECTIVE
Paul is a free-lance independent pharmaceutical consultant active with
US, Irish and Japanese companies primarily focusing on the commercialization
of drug products and quality/ GMP/ regulatory affairs advisement. Paul
is a licensed QP . He was a Senior Director and a member of the board of
Takeda Ireland, a 100% subsidiary of Takeda Pharmaceuticals Corporation-Japans
number 1 Pharmaceutical company and ranked globally as number 12. Using
my international business experience, organizational management and
development ability along with broad technical skills in pharmaceutical
Quality, New Drug Introduction, Regulatory Affairs and Tech. Ops, He
is seeking to service client organizations considering entry to the Japanese
pharma market.
CAREER SUMMARY
31 years’ experience in the Pharmaceutical & Biotechnology industries
IMB/ US FDA/Japanese MHLW experience (Site audit history: 9 FDA, 10 PHRA
(IMB), Japan PMDA, Brazilian and Argentinian authority Audits and multiple
Pfizer, Lilly, Abbott and 3rd party audits)
He has experience in Bulk Manufacturing/Oral Solid Dose/ Sterile &
Non Sterile manufacture/Topical formulations. / Biotech. (7 years including
monoclonal antibody experience).
Green Field experience (new facility start up from site selection to market supply)
Brown Field experience (site development while facility in production)
Company acquisition/merger experience and exercise of due diligence McKinsey consultants trained
He was a recipient of Takeda Global Award.in 2009 (Takeda’s worldwide highest individual merit award).
EDUCATION
Qualifications:
B.A. (Moderator) Natural Sciences. (Biochemistry and Chemistry) (Trinity
College Dublin 1981). M.Sc. (Nuclear Medicine) from St.Vincents Hospital,
Dublin and (University College Dublin) 1983. Diploma in Pharmaceutical
Manufacturing Technology - School of Pharmacy, Trinity College Dublin 1992.
Licensed QP with the Irish Medicines Board.
EXPERIENCE
Independent Quality Consultant/ QP &
Lecturer (Athlone Institute Technology) Present
He lectures 3 rd and final year students of the B.Sc. in Pharm. Sciences and Biotechnology
(Quality Assurance,GMP,Regulatory Affairs and Legislation)
Part time Lecturer in Biochemistry/ Bioprocessing/Protein Biochemistry
Tallaght Institute of Technology Present
Takeda Ireland Ltd (Bray)
Senior Director Drug Product Oct 97 – Feb. 2014
Grelan Corporation (Bray/Tokyo) Jan ‘96 – Oct.97
I was the Director of Technical Affairs and a member of the board.
LEO LABORATORIES (Dublin) ‘90– ‘95
Topical/ Sterile Product Manager
Organon Teknika Ltd (Dublin) April’83-Dec.’89
Translation & Interpretation
Ms. Marie Kyue
Ms. Marie Kyue has worked for a Japanese engineering company as translator,
belonging to its overseas project team for more than 10 years.
During her career she has been involved with several EPC projects including
secondary pharmaceutical plant projects, where she translated various documents
(contractual documents, technical specifications, project procedures, correspondence and so on).
In the area of pharmaceutical engineering, she has experiences of English translation
of specifications and validation documentation for FDA Audit of Pharmaceutical Plants in Japan.
Translation & Interpretation
Ms. Mino Miyamoto
Ms. Miyamoto studied International Law in Human Rights and Education at graduate schools
in the UK (gaining LLM and MA in Social Justice and Education).
The fields that she has translated have been varied, such as model contracts of iCHE
(Target cost contract and Reimbursable contract, from English into Japanese), an SOP
for dietary supplements manufacturing (from Japanese into English), and other documents
related to the FDA (mainly from English into Japanese). Also, she worked as an interpreter
when she was a US NPA Inspector, auditing in the dietary supplements area. She is currently
working as a legal interpreter, as well.
Other consultants
A ： One has worked on drug formation development and research for many
years, and has experience of working in a drug formation research institute.
He is an expert in the clinical field and in CMC/GXP services. He has further
achievements with international associations.
B ： One has worked on drug formation research and development for many
years. He is an expert in CMC services. He has taken out numerous patents
during his career.
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