Qualification

1. Instruct Chinese pharmaceutical companies to meet the requirements of Chinese and international GMP (US, Europe, ICH, WHO, PIC/S, Australia, etc.), including planning, document system establishment, customer training, guidance implementation, operational supervision and acceptance of official audits and an examination;

2. Conduct GMP compliance audits for enterprises;

3. GMP training for enterprises.

Qualification

1. Lead the project team to guide pharmaceutical companies to meet the requirements of China and international GMP (US, Europe, ICH, WHO, PIC/S, Australia, etc.), including new plant construction planning, design review, project management, establishment and operation of GMP system. Accept official audits and inspections;

2. Control, manage and coordinate the implementation progress and implementation costs of the project in charge;

3. Manage and train the personnel of the project team.

Qualification

Provide services for the registration of health products at different stages of the client, to obtain approval documents.

Qualification

1. Responsible for the preparation, translation, review and submission of the registration materials for domestically produced drugs and imported drugs, and meet the submission criteria;

2. Track the progress of project declaration, solve the problems encountered in the registration inspection and declaration process, and coordinate and communicate with relevant government departments;

3. To assist customers in formulating appropriate registration strategies and plans in accordance with the actual situation of the customer and the requirements of the regulations, to provide effective guidance and training to the customers, and to promote the project in accordance with the plan;

4. Master and track changes in registration regulations and support research and development of new products.

Qualification

1. Organizational translation, preparation, review and submission of archives of international drug registration documents (including CEP, DMF, EDMF, ANDA, etc.);

2. To assist customers in formulating appropriate registration strategies and plans in accordance with the actual situation of the customer and the requirements of the regulations, to provide effective guidance and training to the customers, and to promote the project in accordance with the plan;

3. Track the review of the registration documents, promptly reply to the questions in the registration review, and be able to communicate effectively with the official;

4. Master and track changes in domestic and international registration regulations, and support research and development of new products.

Qualification

1. Complete the registration of the preparation product independently;

2. Review and check the registration documents;

3. Coordinate the project allocation and coordination of the registration department, follow up the progress of the registered project, timely discover and deal with the problems in the process of registering the project, and ensure that the department completes the registration task;

4. Establish and maintain good relations with government authorities, coordinate and handle related issues in the registration review process;

5. Train and manage personnel in this department.

Qualification

1. Marketing the company's existing and newly developed service products.

Qualification

1. Brand promotion and maintenance, including event planning and promotion, and specific organization and implementation, expand business, promote cooperation, and enhance brand;

2. Market research and analysis, including collection, collation, analysis and reporting of relevant information;

3. Text editing, publishing and maintenance of the company's website information platform;

4. Customer service and management, including management and update of customer files, collation and improvement of customer data, maintenance of key customer relationships, etc.

5. Assist other departments to communicate with customers and promote the smooth operation of business projects.

Qualification

Responsible for the translation of drug registration materials and the interpretation of international certification inspections.