Quality system consulting
Service Scope：
Consultancy services include domestic PICS/GMP preparation plant new plant planning & construction counseling, PICS/GMP raw material plant new plant planning & plant construction counseling, ISO13485:2016 quality system planning and establishment, GMP/GDP/GTP counseling, agency Service
Consulting Services Items
General Regulatory Interpretation
Consultation for general administrative regulations only, not involving case issues or technical data assessment.
To reward the clients, this general consulting service is for the client who has signed the retainer services contract with the AMSI in principle.- Once the product or issue becomes more complicated and needs to be converted to a project consultation, AMSI will charge a fee.
- AMSI will reply to the clients by e-mail/verahuang@amsi.com.tw. Please be sure to give the correct email address.
Case Strategy Assessment
Set up a project to meet the needs of clients and provide professional customized consultation services.
This consulting service fees will be charged based on the complexity of the case background and the content of the consultation.
AMSI will reply to the clients by e-mail in principle. Face-to-face communication can be carried out if necessary.
If further negotiations with the authorities or a request for written confirmation is needed., AMSI can provide an agent service, which can serve as the client’s local contact window, case submission applicant or product license holder. There will be an additional charge for the government administrative fee.
- If a related study or trial is required, AMSI can provide a suitable service provider according to client needs to find the local professional organization to carry out the project.
Case Submission Counseling
- Set up a project to meet the needs of clients and provide professional customized consultation services.
Consulting service fees will be charged based on the complexity of the case background and the content of the consultation.
AMSI will reply to the clients by e-mail in principle. Face-to-face communication can be carried out if necessary.
If a formal submission to the authorities is needed, AMSI can provide an agent service, which can serve as the client’s local contact window, case submission applicant or product license holder. An additional government administrative fee will be charged.