Beijing Canny Consulting Inc., the earliest medical regulatory consulting company established in China, has always regarded professional training as its entire service system in more than ten years of food and drug registration and GMP compliance consulting practice. A focus.
First, the training content: practical, system practical
Relying on years of research on domestic and international pharmaceutical and health product regulations and frontier information search and tracking, combined with rich experience in consulting practice, Kanglihua has formed a set of relatively mature and complete quality training courses, the main contents of which cover the following businesses:
(1) GMP and engineering
1. China GMP Certification
(1) China's new GMP certification
(2) New (changed) construction factory (workshop)
(3) On-site inspection by CFDA for overseas enterprises
(4) GMP certification for medical device factories
(5) GMP certification for veterinary drug factories
2. International GMP certification
(1) US FDA certification
(2) EU GMP certification
(3) US USP certification
(4) Australian TGA Certification
(5) WHO GMP certification
(6) International GMP third party audit
(7) US NSF certification
(8) US NPA certification
(2) International registration
1. US ANDA application
2. Production and filing of US DMF documents
3. Production and filing of American pharmaceutical container DMF
4. US FDA factory registration, self-identification and NDC application
5. US NDI Notice
6. EU CEP/COS application
7. Production of EU EDMF documents
8. EU generic drug registration
9. EU Traditional Herbal Medicine Registration
10. Russian drug registration
11, Australian drug registration
12, SMF file production
(3) Domestic registration
1. Import/domestic drug registration
(1) Registration of imported and domestic preparations
(2) Import and domestic drug substance registration
(3) Registration of imported and domestic pharmaceutical excipients
(4) Registration of imported and domestic direct contact pharmaceutical packaging containers
(5) Evaluation of the consistency of generic drugs
(6) Import and domestic veterinary drug registration
2. Import/domestic health food registration
(1) Import and domestic health food registration
(2) Import and domestic health food re-registration
(3) Application for technology transfer and technology change registration of imported and domestic health foods
(4) Health Food GMP Certification Service
(5) Registration of new food ingredients
(6) Registration of food additives
3. Import/domestic cosmetics registration
(4) Training & Conference
(5) Business consultants
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Relevant training content will be continuously supplemented and improved according to the latest regulations and practices. "Practical, systematic and practical, bringing the latest and most authoritative relevant regulations and technical training courses for the majority of pharmaceutical companies" has always been the basic quality requirements of Kanglihua for the training business.
Second, the form of training: a variety of customized services
Over the years, Kanglihua has provided registration and certification contract services to hundreds of customers, providing them with targeted training. The content has penetrated all stages and links of the service process, and has cultivated technical backbones for customers and continues to lead the country. Customer registration, certification, and especially the continuous improvement of GMP management and internationalization process.
In response to the standardization and internationalization needs of Chinese domestic pharmaceutical companies, Kanglihua has been closely cooperating and interacting with SFDA, Chinese Pharmaceutical Association, US FDA, European EDQM and USP for many years, and has jointly organized large-scale international training and seminars. Participants provided the most authoritative regulatory/technical information.
At the same time, Conley also provides differentiated “one-on-one” training programs to meet the specific needs of different companies, so that companies can feel the special and targeted preparations from each training. .
At present, the forms of training include: public training, corporate customization and other forms. Since the launch of the business, it has been widely welcomed and positively evaluated by customers.
The key to Kanglihua's successful provision of professional training services is that Kanglihua has the ability to integrate practical experience and deep industry knowledge in the field of pharmaceutical administration. The relevant trainers are experts and consultants from Kanglihua and domestic and foreign companies with professional background registration and GMP compliance. They have many years of practical experience.