GxP System

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)