GxPAssure offers a range of Quality & Compliance support to the pharmaceutical industry.
We have extensive experience in manufacturing compliance, inspection readiness, remediation and more.
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.
GxPAssure Consultants are experts in their field. All our consultants have extensive industry backgrounds and have over 300 years combined experience.
GxPAssure offers world-class support & advice. Our team have a long-standing history of excellence. We provide prompt, accurate & reliable support every time.
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.
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.
GxPAssure offers a range of services to support your Quality & Compliance needs.
We can tailor our support to meet your specific circumstances
We can perform mock regulatory inspections to support your inspection readiness.
We can support remediation and quality improvement initiatives. Our multidisciplinary team can help across a wide range of technical areas.
We can provide an independent review of your systems and processes.
We can perform a range of audits on your behalf. Due Diligence, CMO, Supply Chain, For-Cause, Audits.
We can support with managing and remediating serious regulatory deficiencies. Our team have experience remediating adverse MHRA, FDA and other inspections.
We can provide expert training in technical matters and general quality and compliance topics.
We can provide advice and support on quality & compliance matters and regulatory expectations.
We can support with preparing for regulatory inspection. We offer an end-to-end solution for preparing your operations, systems and processes for approval.
We can offer contract based support for key Quality positions to support your remediation & improvement.
ATMP Manufacturer
GxPAssure supports us with our annual supply chain and CMO audits.
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!
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.
GMP Manufacturing
GxPAssure helped us prepare for EU Regulatory inspection and supported us through the process. We are now fully approved!
GMP Manufacturing
GxPAssure helped us improve our quality systems and operations and supported us with EU and US approval.
ATMP Manufacturer
GxPAssure supports us with our annual supply chain and CMO audits.
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!
We have a wide range of satisfied clients worldwide
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.
Our experts offer more than just a "compliance focus". We offer pragmatic, real-world solutions to often complex issues. All our consultants have lived the challenges personally. Our advice blends high compliance with realistic implementation.
Our philosophy is to be "Always There" for our clients. Whether it is a small issue or a complex project, we can help. We believe strongly in long-term relationships with our clients. We will always be there for our clients and partners.
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 discuss your needs. We can tailor solutions to give you a bespoke solution. Our consultants have extensive experience and technical capabilities.
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.
Info@GxPAssure.com
(+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.
We can provide support rapidly, however consultant availability can be restricted in the short-term. It is advised you contact us promptly to secure availability.
We have a broad range of expert consultants that have extensive experience in GxP topics. We are confident we can support with the right skills.
Contact us to discuss your needs further
Work is typically performed under a Master Service Agreement (MSA) detailing the terms and agreement.
Individual assignments are then detailed in Statements of Work (SoW) detailing the specifics of the tasks to be performed.
We typically charge an hourly rate for our services.
We can negotiate and agree an appropriate fee structure to meet your needs.
Info@GxPAssure.com
London, UK
(+44) 7414 927035
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GxPAssure Ltd. , London
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