Overseas tie-up Consulting Company
NOBIO CONSULTING has been in tied-up with the overseas qualified GXP consulting firms that retain the first-class talents with high specialty. It is therefore guaranteed that you will be satisfied with high quality of our consultations and services, that is comparable to European and American major GXP consulting firms. Please contact us if there is a Japanese or foreign company who are under consideration of development of medical supplies in Japan or overseas, expected to receive an inspection by an authority in the near future, or are concerned about GXP business overseas, such as management and control of contract manufacturer and/or testing organizations in Europe, USA or any other countries, or the vender/supplier of the raw materials, intermediates, final products. Depending on activities requested, we will make a proposal, after consultation with our business partners, for what consultations would be matched with you under full satisfaction. Therefore, it may happen to introduce additional third-party consultant, if we determined that will be the best.
The following is a consulting firms working under a business partnership.
- PHACT GmbH
- https://phact.ch/
- Mr. Lothar Hartmann, CEO was used to be responsible for the effective implementation of a quality management system at Roche/Genentech. He also served as a director and a scientific board member of PDA. Currently he is chairing PDAs global Interest Group on ‚Quality Systems developing “best practices” on ICH Q10. Furthermore, he is engaged in ISPEs Interest Group on, Pharma 4.0' outlining the transformation process towards digitalization.
His company (Phact GmbH, https://phact.ch) is located at Basel in Switzerland and is doing business actively over Europe countries. They are also enjoying a good reputation for consultation for EMA inspection as well as pharmaceutical affaires."
- LENAPE PHARMA GMP Solutions, LLC
- https://www.lenapepharma.com/
- David Moyer is President and CEO of Lenape Pharma and Senior Consultant focused on providing expert, hands-on support on matters pertaining to Quality Management Systems and cGMP Regulatory Compliance, including Data Integrity and Quality Metrics, for Pharmaceutical and Biopharmaceutical companies. David previously served as Senior Director, Vice President at ICON, Head of Quality Assurance at RTP Diosynth (formerly Covance Biotechnology Services), and Vice President at Phoenix Regulatory Associates, Ltd. He also headed up Quality Assurance group at Somatogen, Glaxo and Burroughs Wellcome. He has provided primary hosting and coordination of more than 50 FDA inspections associated with new drug approvals, compliance actions, and routine drug surveillance; coordinated preparation and hosting of 8 EU Regulatory Authority GMP inspections; performed greater than 350 "mock" FDA inspections of suppliers in the US, Europe, Japan, India and China.
- GZ 21st Century GXP Auditing Services, LLC
- gezu.mengistu@gzauditing.com
- Mr. Gezahegn Mengistu, CEO is an Executive Quality Professional with over 22 years of GXP audits, quality management, manufacturing experience, technical regulatory submission strategies, and regulatory inspection readiness experience within regulatory focused global environments. Established experience in GXP Audit Organizations, Quality Assurance, Manufacturing, and Pharmaceutical Technical Regulatory of Genentech Inc., USA, F. Hoffmann-La Roche Ltd., Switzerland, Bayer, USA, NSF Health Sciences Pharma Biotech. HIs expertise is not only for the field of medical supplies (in particular, biotechnology) but also the medical device (combination products) field. He is active in North America, Europe, the Middle East and Africa.