GxP System & Training
Whether you’re a start-up business or an already established global company looking to expand, AXSource Consulting’s professional GxP services will provide you with cost-effective initiatives and processes to meet stringent governing pre-clinical (GLP), clinical (GCP), production (GPP), and manufacturing (GMP) practices, post marketing (GVP) and including testing, packaging, labeling, importation & distribution (GDP).
We have even coined the term “GRP” for Good Relationship Practices!
Give us insight into your products, services, prospective market, and global or local partners, and we will establish a robust business process framework that will withstand the test of time and the scrutiny of intense regulatory inspections.
AXSource consultants will support the development of your business process framework with formal policies, procedures, documents and recommended automated tools to improve your bottom line.
Our services include:
Customized GMP, GLP and GCP documentation based on your products and services
GxP Implementation and Staff Training
GMP Pre-approval Inspection (PAI) Readiness
Consultant Audits (Health Canada GUI-0080)
Self-Inspection or Internal Quality Audits
Regulatory Agency Inspection Hosting and Follow-up coordination
Supplier (CRO, GLP, API Vendor) selection and evaluation
NHP Manufacturing GMP audit & Quality Assurance Report (QAR) Preparation
GMP Auditor Training
Remediation strategies for non-compliant status
GxP best practices for benchmarking
Good Clinical Partners (GCP)