Pharmaceutical Quality & Compliance Services

OUR SERVICES

What We Provide

GxPAssure offers a range of services to support your Quality & Compliance needs.

We can tailor our support to meet your specific circumstances

Mock Inspections

We can perform mock regulatory inspections to support your inspection readiness.

Remediation

We can support remediation and quality improvement initiatives. Our multidisciplinary team can help across a wide range of technical areas.

System Review

We can provide an independent review of your systems and processes.

Audits

We can perform a range of audits on your behalf. Due Diligence, CMO, Supply Chain, For-Cause, Audits.

Regulatory Censure

We can support with managing and remediating serious regulatory deficiencies. Our team have experience remediating adverse MHRA, FDA and other inspections.

Training

We can provide expert training in technical matters and general quality and compliance topics.

Consulting

We can provide advice and support on quality & compliance matters and regulatory expectations.

Inspection Readiness

We can support with preparing for regulatory inspection. We offer an end-to-end solution for preparing your operations, systems and processes for approval.

Contractor Support

We can offer contract based support for key Quality positions to support your remediation & improvement.

Areas We Support: Sterile ManufacturingBiologics ManufacturingATMPsCell & Gene TherapySmall MoleculesBespoke Projects

We support a wide range of therapeutic areas, dose forms and technology types. We have expertise in Sterile Manufacturing, Biologics Manufacturing, ATMPs, Cell & Gene Therapy, Small Molecules and Others.

Expert Consultants

GxPAssure Consultants are experts in their field. All our consultants have extensive industry backgrounds and have over 300 years combined experience.

Reliable Support

GxPAssure offers world-class support & advice. Our team have a long-standing history of excellence. We provide prompt, accurate & reliable support every time.

Flexible Team

GxPAssure can work flexibly to suit your specific needs. Our team is comprised of ex-regulators and skilled contractors. We can support on-site or remotely.

If You Need Help, Get A Consultation

FAQ

General Questions

What Kind of Projects Can You Support?

We can support all kinds of projects and assignments. From short-term support, audits and ad-hoc consulting to longer-term quality improvement and remediation.

How Quickly Can You Offer Support?

Do You Have The Expertise We Need?

How Do You Typically Structure Work?

What Are The Typical Costs?