Consulting Services
Professional Services
GxP Systems Consulting
When you choose GxP consulting, you are a start-up client wishing to cost-effectively and with appropriate expertise, implement processes to meet stringent governmental regulations governing non-clinical (GLP), clinical (GCP), and manufacturing (GMP) practices including testing, packaging, labeling and importation & distribution.
Give us your insight into your services, products, prospective market, global or local partners and we will establish your robust business process framework that will withstand the test of time and scrutiny of intense regulatory inspections.
AxSource’s experienced consultants will support the development of your business process framework with formal policies, procedures, documents and required tools.
We have even coined the term "GRP" for Good Relationship Practices. Call us and enquire.
Our Services include:
- Customized GMP, GLP and GCP documentation based on your products and services
- GxP Implementation and staff training
- Pre-approval GMP Inspection Readiness
- Consultant Audits (GUI-0080)
- Self-Inspection or Internal Audit Outsourcing
- Health Canada Inspection Hosting and Follow up coordination
- Supplier (CRO, GLP, API Vendor) selection and evaluation
- NHP Manufacturing GMP audit & Quality Assurance Report Preparation
- GMP Audit training
- GMP correction actions support and closure of non-compliance noted by regulatory agencies
- GxP best practices for benchmarking