Company Overview
For over a decade GXP CONSULTING a Global Consulting firm has established a reputation for providing the highest standards of compliance expertise in GLP, GCP, GMP and GPV to small and mid sized pharmaceutical and biopharmaceutical firms throughout the lifecycle of their clinical programs, i.e. From Concept through Commercialisation ™. We are the Compliance Experts who can provide proven expertise throughout your clinical program lifecycle!
GXP Consulting has a growing team of full-time permanent consultants, each with an average QA experience of over 15 years, based across the globe. We have many former regulators and inspectors in our organisation, who can quickly and effectively help you mitigate GxP compliance risks and manage any remedial activity you are involved with.
Unfortunately it is the norm for most start-up pharmaceutical and biopharmaceutical firms to wait until they get to Phase 3 to implement compliance controls which often result in dire consequences for their clinical programs, where the submission to regulatory agencies are delayed or denied altogether for the lack of the appropriate compliance controls. Regulatory agencies require the appropriate compliance controls be implemented throughout the lifecycle of the clinical program; not at the latest phase just before submission. We have the expertise of working with our biotech and pharma sponsors throughout their clinical program lifecycle i.e. “From Concept to Commercialisation ™”
If you are a small start-up who lacks the financing to hire a full complement of GXP( GLP, GCP and GMP) professionals to implement Phase appropriate quality systems, perform the required compliance oversight of your clinical programs, then our seasoned GXP Consultants can help. We will work with you throughout your clinical program lifecycle and when you are ready to file your NDA, we will help you prepare for and successfully host both the GCP and GMP Inspections, so contact us today for a compliance assessment of your clinical programs.
We have also worked with established firms to perform gap assessments of their clinical programs and systems and then implementing the appropriate controls to enable them to undergo successful agency inspections or to remediate current systems to meet regulatory standards.
Leading the way in building GLP, GCP, GMP and GPV Compliance
Our mission
- We will work with you throughout your clinical program lifecycle to implement a robust compliance program that meets regulatory requirements.
- When you are ready to file your NDA; we will help you prepare for and successfully host both the GCP and GMP Inspections.
- So contact us today for a compliance assessment of your clinical programs.
Check our Video Pesentation
The GXP Compliance Experts.
We have never failed a BiMO or PAI inspection and we have remediated many failed BiMOs and PAI’s ectors for over a decade