日本語 / English

NOBBIO Consulting LLC

Tel
:
043-286-1557
Mail
:
tateishinbo@nobbio.net

We are professional consultants guaranteeing global level service to support GXP activities in development and commercialization of medicinal drugs,
regenerative medicinal products, medical device and cosmetics, etc.

It is well known that for commercialization of a pharmaceuticals, regenerative medicinal products, and/or medical device etc., it is necessary to establish the safety and efficacy of the products through clinical investigation, and thus a 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 and confirmed through process performance verification (PPQ) 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, and validation if necessary, through adequate change control procedure.

The control strategy for product quality shall be well managed from early development stage by accumulating scientifically acceptable data to prove the safety and efficacy of the product candidate 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. Particularly, if your product is expected to market overseas (in Europe and/or USA) you must bear in mind that there are some differences between these countries and Japan in regulatory requirements and practices, and thus it will be a key to work together with talented consultants who are very familiar with such regulations and rules, and well experienced to prosecute the license application before the authorities in order to receive an expedited review by authorities for marketing approval. For example, final approval for the product importation and release into Europe shall be made by Qualified Person under EU regulation and thus close cooperation with Qualified Person, including auditing your manufacturing sites, are necessary for clinical and/or commercial supply in Europe.

After approval of commercial marketing license, the high level of (pharmaceutical) quality management system (PQS/QMS) 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 a responsibility of the senior managers to establish and well control, and then oversite such a (pharmaceutical) quality assurance system. Accordingly, FDA and EMA will check the effectiveness of your PQS/QMS during their inspection and if any GMP deficiencies are found, enforcement of effective CAPA will be ordered to the senior managements.

NOBBIO Consulting is one of the qualified consulting firms in Japan with high level of specialties and experiences in GXP field, including abundant experiences and technical knowledge about product development and commercialization and further many experiences of compliance activities for auditing or inspection by authorities. In addition, we have 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 at big global pharmaceutical companies, bearing the responsibility to manage and establish 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 for compliance with global GXP regulations for medical supplies, in accordance with appropriate development stage, i.e. from pre-clinical and clinical development stage to commercial manufacturing stage after approval of a marketing license . Consultation service is also available to help you for a meeting with authorities for consultation of product development and strategy for approval, documentation issues (CTD filing) for commercial license and any quality issues encountered during the development. If you are concerned about safety and completeness of your supply chain, we will be excellent to help you to provide compliance activities including audit of the suppliers’ manufacturing and testing facilities around the world, and further help you in managing and preparing readiness for inspection by global authorities, like FDA and EMA etc.

The features of NOBBIO Consulting LLC

1.High specialties in compliance activities with abundant knowledge of GXP regulations in EU and USA
NOBBIO Consulting assures its human resources have specialties in GXP field and abundant experiences of conducting audits to manufacturing and testing sites globally 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 at big global pharmaceutical companies, so that we are enjoying a good reputation as specialists in specific area of quality issues, such as process and cleaning validation, deviation handling including CAPA management, Quality by Design (QbD) and changes after approval (Q12), data integrity and computer system validation, quality risk management, and compliance with GDP requirements in Europe and USA, such as falsification prevention measurements and documentation of distribution records . You will therefore be entrusted to receive reliable advice and supports for GXP compliance, and further help you to 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 not be provided by other Japanese consulting firms that retain experts from engineering firm, equipment and device suppliers or domestic pharmaceutical companies.
2.Abundant experiences about GXP 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, particularly in the field of aseptic products, bioproducts and regenerative medicinal products in USA, Europe, Taiwan, China, South Korea, Singapore, and India. Our overseas business partners also have abundant experiences of audits as well, even in chemical API and formulations (solid or liquid) field, so that you will be capable to effectively manage and supervise such companies through our services or our overseas business partners. Bearing in mind that the contractors and suppliers management is one of the major GXP issues and shall be checked to be in compliance with expectation by the authorities, our support for due diligence inspection and/or periodical audits would contribute to strengthen your quality assurance system for oversight and supervision of the facilities running by third parties. Further, our services can help your contract activities for contract-manufacturing agreement, supply agreement and also quality agreement, as well as registration and maintenance of (Drug) Master File, foreign manufacture accreditation and domestic agent activity etc. These activities need special technical knowledge and language skills, and thus you can rely on us as we manage them through direct communication with the pertinent parties without bothering your business. Our highly qualified services encompass deviation and OOS handling, CAPA management , validation activities, data integrity, training and so on. It shall be noted that these services would in turn contribute establishment of quality culture and thus be beneficial to your preparations for authority inspection. You will be finally satisfied with a quick resolution about any compliance risks concerning overseas facilities even in an early stage of your project, that would lead to considerable reduction of unnecessary expenditure.
3.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, and prospective changes of GXP regulation and guidance by global authorities, so that you can strengthen and reinforce the sustainable (pharmaceutical) quality management system ensuring compliance to the latest regulatory requirements over a product life cycle throughout our consulting service including in-house seminar . If you are facing to receive the inspection by domestic or overseas authorities shortly, we will arrange for mock inspection and provide you quickly with our expert advice about any deficiencies of your facilities in GXP compliance requirement and corrective actions as necessary. We also offer to help you for inspection management and readiness, such as preparation for necessary documents, strategy for pre-review and pre-check, training for how to respond to inspectors, etc.