GxP Consulting Worldwide

Pharmaceutical Compliance Consulting

GxPAssure offers a range of Quality & Compliance support to the pharmaceutical industry.

We have extensive experience in manufacturing compliance, inspection readiness, remediation and more. 

WELCOME TO GXPASSURE

We Can Support Your Quality & Compliance Needs

GxPAssure offers a range of support to the pharmaceutical industry. We can provide access to an expert team of consultants with a wealth of experience across the GxPs.

Ian Ramsay

Founder & CEO

SEND A MESSAGE

Request a call back

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.

0 +

Projects Complete

0 +

Countries

0 +

Years Experience

0 +

Team Members

OUR CORE TEAM

Meet Our Core Team

Meet our Core Team responsible for co-ordination and logistics of our wider team of consultants

Portrait of Ian Ramsay, owner of GxPAssure

Ian Ramsay

Founder & CEO

Portrait of Nicole Ramsay

Nicole Ramsay

Admin & Support

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.

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.

Iceland Biosimilars Manufacturer
Iceland Biosimilars Manufacturer

GMP Manufacturing

GxPAssure helped us achieve US-FDA and EMA approval for our novel biosimilar facility. Swift approval of our new facility really made the difference!

UK Specials Manufacturer
UK Specials Manufacturer

GMP Unlicensed Manufacturing

GxPAssure helped us to respond to, remediate and move beyond a serious MHRA IAG referral. We are now fully compliant and out of IAG.

China Biosimilars Manufacturer
China Biosimilars Manufacturer

GMP Manufacturing

GxPAssure helped us prepare for EU Regulatory inspection and supported us through the process. We are now fully approved!

Taiwan Biologics Manufacturer
Taiwan Biologics Manufacturer

GMP Manufacturing

GxPAssure helped us improve our quality systems and operations and supported us with EU and US approval.

USA Cell & Gene Manufacturer
USA Cell & Gene Manufacturer

ATMP Manufacturer

GxPAssure supports us with our annual supply chain and CMO audits.

TESTIMONIALS

What Our Clients Say

We have a wide range of satisfied clients worldwide

COMPANY'S VISION

GxPAssure's Vision

To support the pharmaceutical industry in providing the best possible quality products for patients.

To provide the highest possible level of expertise, advice and support to our clients. All our consultants are experts in their fields and highly experienced.

CASE STUDIES

See Our Latest Projects

GxPAssure undertakes a wide range of client assignments and projects worldwide.

The following are a selection of example projects we have undertaken

Contact Us to Learn More

Contact Us to discuss your needs. We can tailor solutions to give you a bespoke solution. Our consultants have extensive experience and technical capabilities.

Support

We can offer ad-hoc support or structure longer-term packages. We are specialists in more complex remediation and inspection readiness projects. Our staff can offer contract support for more complex and longer-term assignments.

Phone Number

(+44) 7414 927035

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.