Achievement

Achievement

Beijing Canny Consulting Inc. was established in 1998, focusing on pharmaceutical regulatory compliance, pharmaceutical and related health product registration consulting services, including China and international (Europe, the United States, Australia-based) GMP certification. New factory construction; international registration (ANDA, API, accessories, packaging materials, etc.); domestic registration (imported or domestically produced preparations, API, accessories, packaging materials, health foods, cosmetics, disinfectants, etc.); corporate perennial drug policy consultants and Investment and financing project industry consultants, etc.

In May 2014, Beijing Kanglihua Consulting officially became a holding subsidiary of Tiger Pharmaceuticals (stock code: 300347).

  • / The FIRST consultancy in china to provide GMP certification consultation services /

  • / The FIRST consultancy in china to help an API manufacturer to accomplish FDA cGMP certification /

  • / The FIRST consultancy in china to help a company to obtain the COS/CEP certificate /

  • / The FIRST consultancy in china to help a company to close an FDA Warning Letter /

  • / The FIRST consultancy in china to help a company to reactivate a suspended COS/CEP certificate /

  • / The FIRST consultancy in china to help a company to file a Type III DMF with USFDA /

  • / The FIRST consultancy in china to help a company to file a Type IV DMF with USFDA /

  • / The FIRST consultancy in china to carry out European FAMI-QS certification /

  • / The FIRST consultancy in china to help a company to pass FDA cGMP inspection with “Zero deficiency” /

  • / The FIRST consultancy in china to help a company to pass GMP inspection in New Zealand /

  • / The FIRST consultancy in china to help a sterile API manufacturers to pass FDA inspection /

  • / The FIRST consultancy in china to help a overseas company to pass CFDA on-site inspection /

  • / The FIRST consultancy in china to help a biologics manufacturer to pass EU GMP inspection /

  • 1/ GMP Certification And Engineering
    1/ GMP Certification And Engineering

    There are more than 350 GMP certification cases in China, Europe, America, France and Australia (including more than 100 international inspection success cases in Europe, the United States, Australia, etc.). The relevant product formulations include: injection and freeze-dried powder injection ( Including biological products, blood products); large infusion agents; oral preparations; non-sterile/sterile bulk drugs.

    More than 50 successful cases of FDA on-site inspections, of which FDA examined "zero defects" through 8 cases.

    EDQM has more than 50 successful cases on site, with a pass rate of 100% (the highest in the world - 84% in Italy).

    More than 10 successful cases of TGA on-site inspection in Australia.

    2/ International Registration

    More than 300 cases (including raw materials, containers and preparations) are registered in the United States.

    More than80 European Union Pharmacopoeia Certificates (COS/CEP).

    More than 80 European registrations (including EDMF/ASMF documents).

    More than 20 cases of Australian TGA Drug Registration (ARTG), including prescription drugs, over-the-counter drugs and supplementary drugs.

    2/ International Registration
  • 3/ Product Registration in China
    3/ Product Registration in China

    Imported/domestic drug products, more than 40 cases.

    Imported/domestic APIs/excipients and packaging materials/containers, more than 80 cases.

    Imported/domestic health food, more than 60 cases.

    Imported/domestic cosmetics filing/registration, continuous services are provided to more than 100 brands.

    Quality Consistency Evaluation for Generic Drugs projects conducted, more than 10 cases.


    4/ Training & Conference

    He has organized more than 10 international academic seminars in cooperation with drug regulatory agencies and industry associations at home and abroad, and has undertaken translation work for the conference.

    4/ Training & Conference