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IDL ability
Description

Excellent Regulatory Ability

 

 ▲ Registration Dept.: In 2015, CSC established a technical department by its own staffs. Now CSC has a grand technical department with 25 team members, consisting of 2 doctors and 5 postgraduates, the RA head has over 20 years’ industry experience, which enables CSC’s MA application work more direct, efficient and successful.


 ▲ Achievements: CSC has completed registration of more than 100 APIs since 2005.

 With constant improvement of MA work, CSC has got rich experience in the confidential system and   management work of CTD dossiers, no dossiers had been leaked in the past 13 years.

 

 ▲ Reputation: Through years of MA experience, CSC’s RA team has earned a good reputation from NMPA and built effective communication channels with NMPA.

 

 ▲ Technical support: With its stable and professional team and modern laboratory, CSC has large ability of supplementing and improving the registration documents and dossiers, which can satisfy urgent requirements both from suppliers and customers. 

 

 ▲ Confidentiality measures

        Hardware system: All printing machines in public areas are monitored by camera 24 X7. A certain number of printings need superiors’ permission.

        Software systems: (1) File encryption system: all files are self-locked, if anyone wants to send any file to outside, the files should be sent to Administration Dept. for reviewing & approval first. Or else, the files can't be opened by the receiving party; (2) USB is not readable in our office computers, photocopying is not allowed; (3) There are strict limits to how many bytes can be copied.

        Structure: The registration team is divided into two groups, only dept. head has access to the entire set of DMF, other members are responsible for specified modules only. Which enable CSC well fulfill the obligation of confidentiality agreement signed with business partners.

 ▲The differences between registration agents and CSC:

       Motivation: For registration agent, registration is their business. They make profits in each phase.Hence, applicant has to pay high costs including official and non-official costs, especially those non-official costs. However, CSC's ultimate aim is to get the MA for marketing. Furthermore, CSC bears all MA costs.

       Responsibilities: Registration agents do the filing with their own professional accomplishments, they take limited responsibility, they would not make full efforts to get final MA. However, CSC would. Because we invest huge for filing with the strong desire to achieve reasonable margin it may bring to us. Therefore, we take the MA job much more seriously than any other registration agents.

 

 

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