We are professional consultant guaranteeing global level support service to GXP activities in development and commercialization of medicinal drugs, medical device and cosmetics, etc.
It is well known that for commercialization of a pharmaceuticals, regenerative medicine products, medical device and/or cosmetics etc., it is necessary to establish the safety and efficacy of the products through clinical investigation, and thus planning of the strategic approach for how to achieve assurance of the product quality securing the safety and efficacy, is quite important even from early development phase. In other words, the control strategy for manufacturing and quality control of the product shall be established during the development stage, as the control strategy will play an important role to assure the robustness of the manufacturing process during commercial production. You will be required to clearly write down such information into commercial license application (CTD) with scientific sound. In Europe and USA, the detailed information for how to perform manufacturing and quality control is demanded to describe into a clinical trial application (Investigational New Drug (IND) application and Investigational Medical Product Dossier (IMPD)) and you are also expected to comply strictly with its descriptions for manufacturing and quality control and further to keep the timely update of the dossier.
The control strategy for product quality shall be managed from early development stage by accumulating scientifically acceptable data to prove the safety and efficacy of the product and evaluation of such data shall be performed under compliance with the requirements of GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), GCTP(Good Gene, Cellular, and Tissue-based Products Manufacturing Practice),GDP (Good Distribution Practice) and GCP (Good Clinical Practice), so that special expertise with technical knowledge is needed to accomplish this task. Further, evaluation of such data shall be made under close cooperation with Qualified Person, if the products are used for clinical trials at Europe.
After approval of commercial marketing license, the high level of quality management system is required to meet severe requirements under GQP (Good Quality Practice) as well as GMP (GCTP) and GDP, and the global regulations state clearly that it is the responsibility of the executive managers to establish and well control and oversite such a (pharmaceutical) quality assurance system.
NOBBIO Consulting is one of the qualified consulting firms in Japan with high level of specialties and experiences in GXP field, and further has established a global business network with qualified overseas GXP consulting firms that retain the talented persons with experience of a director or senior manager of Quality (Assurance) function of big global pharmaceutical companies, bearing the responsibility to manage and control the effective quality assurance systems for the investigational medicinal products and/or commercial drug products. You therefore will be able to receive the excellent services with global compliance guarantee to GXP regulations for medical supplies, appropriately pertinent to a development stage. Consultation service is also provided to a meeting with authorities for consultation of product development for approval, documentation (CTD filing) for commercial license and quality issues for the manufacturing, and further preparation for inspection by global authorities, etc.
The features of NOBBIO Consulting LLC
High specialties with deep knowledge about GXP regulations in EU and USA
NOBBIO Consulting ensures human resources with specialties in GXP field and abundant experience of global audits and/or hosting inspections by overseas authorities, through establishment of a global business network with qualified overseas GXP consulting firms that retain the talented persons with experience of a director or senior manager of Quality (Assurance) function of big global pharmaceutical companies, including management and cooperation to authorities like FDA and EMA for quality issues or inspection. You will therefore be entrusted to receive reliable advice and supports for GXP compliance, and further help you establish a rigid quality assurance system to comply with the latest global GXP regulations. These high specialties in regulatory compliance will bring absolute technical and business advantages which can't be provided by other Japanese consulting firms that possess experts from engineering firm, equipment and device suppliers or domestic pharmaceutical companies.
Deep GXP experiences about business with overseas facilities
NOBBIO Consulting retains an experienced person in managing and controlling business with overseas contract manufacturers and testing organizations, or raw material venders/suppliers. It is thus capable to effectively manage and supervise such companies by our services or through our overseas business partners. Bearing in mind that the contractors and suppliers management is a critical GXP issue and shall be performed in light of expectation by the authorities, our support for due diligence inspection and/or periodical audits would constitute a key for your quality assurance system to oversight and supervision of the facilities. Further, our services extend to contract activity for registration and maintenance of Drug Master File, etc. These activities need special language skills and we can manage them directly without bothering your business.
Our highly qualified services encompass handls on management for deviation control, CAPA, validation activities, data integrity, and so on.
It shall be noted these would be in turn preparations for authority inspection, so that a quick resolution about any risks for compliance by overseas facilities shall be achieved in an early stage, and we will provide excellent advice to you, which leads to reduction of unnecessary expenditure.
Guaranteed for sustainability of GXP compliance
NOBBIO Consulting has established a business system to collect, by ourselves or through cooperative overseas consulting firms, the latest information about the inspection trends by FDA and EMA or prospective changes of GXP regulation and guidance, so that you can strengthen and reinforce the sustainable (pharmaceutical) quality management system ensuring compliance to the latest regulation over a product life cycle. If there is a Japanese company that is facing to receive shortly the inspection by domestic or overseas authorities, we will provide you quickly with our advice for suitability of your readiness for inspection and corrective actions necessary, after conducting mock inspection.