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Jiushun Managemen Profile

Shanghai Jiushun Enterprise Management Technology Co.,Ltd.( Jiushun Management ) is a professional institution providing the services as all kinds of system certification consultation, medical device certification consultation, CFDA registration consultation, European Authorised Representative service, medical device add-value service, certification training, management training and management consultation. At the same time as the only training institution of NECCA in Shanghai.

The medical device certification consultation mainly include: ISO13485、 YY/T0287、CE、PPE、FDA、FDA QSR820、CMDCAS、PAL、TGA, etc.

Drugs and Drug Package Material: FDA GMP CFR 210 & CFR 211/FDA inspection, EU CEP inspection; USA ANDA application, EU CEP/COS application, EU CEP/COS changes and update, USA DMF production and filing, EU ASMF/EDMF application, ICH, CTD and eCTD, generics consistency evaluation, equipment validation consultation, process validation consultation, clean workshop engineering consultation, biological laboratory design consultation, drug registration consultation,

And all kinds of training for drug firms.

Food and Cosmetics: Health food registration consultation, health food recording consultation, health food technology technical transformation consultation, health food GMP consultation, international HACCP certification, registration of medicinal cosmetics, cosmetics GMP design, cosmetics quality control consultation；

Clinical trial consultation;

CFDA registration consultation mainly include: domestic production license, domestic GMP, domestic product registration , imported product registration, in vitro diagnostic reagent registration, etc.

European authorised representative service.

The medical device add-value service mainly include: registration of MHRA, certificates of free sale, Transaction of certificate notarization, clinical test consultation for medical device, translation for medical file, medical device GMP, drafting standards, perennial certification consultation adviser, second party audit, design and construction of the clean room, etc.

The system certification consultation mainly include: ISO9001、ISO14001、OHSAS18001、ISO/TS16949、ISO17025、ISO17020、ISO15189、CMA、ISO22000-HACCP、QCO80000、ISO20000、ISO27000、SA8000、TL9000、IRIS、AS9100C、HSE、FSC、GB-T23331、PAS 2050, etc.

The certification training, management training and management consultation and so on.

On August 3,1996, certification experts Gemmy Song and several certification experts in the same camp jointly established Jiushun Enterprise Management; On September 28,1998, head office was set up in Shanghai; In September of 2000, Jiushun Enterprise Management self-purchased office property, owned itself office.

Since its established in 1996, Jiushun Enterprise Management successfully has provided professional consulting services for more than 5,000 companies and organizations of nearly 39 categories in all walks of life ,such as the medical device, software, information technology, non-ferrous metal, building materials, electronics, electricity, machinery, home appliances, communication, petrochemical industry, scientific research, textile, food, property management, warehousing, logistics, freight forwarders, engineering supervision, etc. Jiushun Enterprise Management raises large numbers of management system professionals of national qualification and register by China Certification and Accreditation Association Personnel Registration Committee (CCCA) (original CNAT, CRBA, CNAB registration) for the enterprise and society.

Jiushun Enterprise Management meets the registration requirements of country to certification consulting institution in the aspects of hardware facilities, human resources, service process control, training process control, documentation control, customer complaint management, etc. It gets Certification and Accreditation Administration (CNCA) approval documents,  approval number: CNCA - Z - 02Q - 2002 – 034,it gets record by Shanghai Bureau of Quality and Technical Supervision （record  number: Shanghai-029-2002）,it is the authoritative institution in consulting industry .It gets authorized by NECCA (former National Quality Authentication Training Centre) (authorized number: NECCA - 2000-002),it gets authorized by China Green Material Symbol Workstation (authorized number: green label qualification word 2004-0420) and it is the membership of Shanghai Authentication Association (membership number: the SCA - ZX 0023).

Jiushun Enterprise Management put into considerable resources to take part in work of technical r&d and personnel training, in order to maintain leading position in consulting service project scope and related technical fields.

All kinds of certification consulting service quality and the professional level of Jiushun Enterprise Management gets the universal praise from customers and gets the highly evaluation of certification institutions.

Jiushun Enterprise Management emphasize “with highly quality consulting services development with the high demand of enterprise ”, set up a set of advanced management system for the enterprise, and realize the sustainable development of the enterprises. Jiushun Enterprise Management adhering to the “ JiuShun enterprise management create value for you” as business philosophy, and incessant innovation, extension and development.