Xizimed is competent in various types of registration applications for APIs, excipients and packaging materials, including DMFs, CEP/ASMF, and GMP compliance services.

The development guidance and registration of APIs, excipients and packaging materials is the most distinctive service board of Xizimed, and Xizimed has very proud service experience in this field.

For imported registration projects of APIs, excipients and packaging materials, firstly  Xizimed carries out a Gap Analysis of existing materials based on the review of CDE for each project, communicates with the customer to grasp the characteristics and difficulties of the project, matches a project leader with more than five years of similar project management experience for the project, establishes a team for the project registration, customizes the project implementation plan, assists the customer in the work, improves the success rate of the registration of APIs, excipients and packaging material products.

For domestic registration projects of APIs, excipients and packaging materials, in addition to providing regular registration services, Xizimed prepares R&D trial strategies or provides the methods of data collection based on the demand of the project; For projects that require outsourcing experiments, Xizimed recommends suitable laboratories based on the characteristics of the project, strives to help enterprises complete the R&D and registration of domestic APIs, excipients and packaging material projects better, faster and more economically, and avoid detours.

In addition, Xizimed has maintained good communication with evaluation institutions for a long time, can accurately understand the requirements of the evaluation center, efficiently assist customers in communicating with evaluation experts on relevant technical issues during the registration process, answer the questions from evaluation experts, or provide supplementary dossiers according to the requirements of evaluation experts.