This is a list of our GXP consulting services.
GXP Consulting
GMP（Good Manufacturing Practice)
- Validation Consulting
- SOP Consulting
- Training
- Facility Renovation & Expansion
- CSV Consulting
- DI Consulting
- the Clinical GMP
GCP（Good Clinical Practice)
- We perform proxy auditing for CRO on behalf of the sponsor.
- We conduct GCP training for the client so that they can learn GCP sufficiently.
GEP（Good Engineering Practice)
- We provide proposals for appropriate facility installations which meets the latest GMP and customer requirements.
- We perform construction management on behalf of customers.
- We provide support for the production facility maintenance plans.
GQP（Good Quality Practice)
- We support for creating GQP documentation in order for clients to get the license of Marketing Authorization holder.
- We provide the draft of GQP SOPs which meets to the client’s and regulatory authorization requirements.
- We conduct GQP training for the client so that they can learn quality assurance sufficiently.
GVP（ Good Vigilance Practice)
- We support for creating GVP documentation in order for clients to get the license of Marketing Authorization holder.
- We provide the draft of GVP and/or GVSP SOPs which meets to the client’s and regulatory authorization requirements.
- We conduct training for the client so that they can learn safety management sufficiently.
GDP（Good distribution practice)
- We support for establishing the client’s system which meets to the global GDP like a WHO and PIC/S.
- We conduct training for the client so that they can learn GDP guideline sufficiently
- We support for creating the SOP in order to manage and operate GDP.