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Tel:024-31231356
Add:Hangtian Road 16th, Hunan District, Shenyang
English > Business unit > EU GMP and c GMP Consult
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With the internationalization of China's pharmaceutical industry, Chinese pharmaceutical companies and innovative drug research and development companies with forward-looking and ideal are striving to improve their own strength, the shortest board is the soft power--quality management system construction and implementation. Mutual Tech is willing to share the experience of our experts in the international registration of the pharmaceutical industry for many years, and hopes to protect and escort the Chinese pharmaceutical companies on the road of internationalization. From the GLP laboratories and APIs developed by innovative drugs to the FDA/EU GMP consultation on the production quality management system of pharmaceutical preparations, our experts can give the most professional guidance and services.
 

Mutual Tech has successfully guided many enterprise hardware concept design and provided a variety of cGMP software consulting services. We can also help customers understand the requirements of FDA and COS, and has assisted many domestic enterprises to pass FDA registration and EU GMP certification. We provide comprehensive solutions for the development of China's pharmaceutical industry, food, food additives and food contact materials, including conceptual design, CGMP, GLP quality management system construction. DMF, ANDA, NDA, IND documentation; BE, clinical trials, product testing implementation; Preparations for inspections such as FDA/EMA, registration of products, NDC numbers, PIN number applications, etc.

 service items

FDA registration of chemical raw materials, various types of preparation products (oral preparations, external preparations, sterile preparations, biological products, etc.), OTC, plant extracts, foods, health foods, food additives, food contact substances, medical devices, etc. Including DMF, ANDA, NDA, IND and other documents; NDC number, PIN number applications, FCN registration, etc.; BE, clinical trials, product testing implementation.

CE certification for chemical raw materials, plant extracts, and various types of preparations (oral preparations, sterile preparations, etc.).

Key pharmaceutical intermediates customer audit related matters refer to GMP-management

Service Content

Planning and leading the implementation of cGMP-related projects The overall solution from project review to agent registration

Initial project review and overall planning (comprehensive solution)

DMF, ANDA, NDA, IND documentation

BE, clinical trials, product testing

Hardware design, review; conceptual design of new projects     

Establishment of quality assurance system and documentation

staff training

Operational guidance (production, production dosage form, aseptic operation, etc.)

Verification (can be implemented separately)
    Equipment pre-confirmation
    Equipment verification
    Process Validation
    Cleaning verification
    Computer system verification
    Laboratory specification
    Utility system verification (water system, air conditioning system, etc.)
Agent registration

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