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GxP Auditing
- Independent risk-based audits
- GMP, GLP, GCP, GDP & GVP
GxP Cellators is a distinguished contract services organization that offers Good x Practices (GxP) services in Manufacturing, Laboratory, Distribution, Pharmacovigilance, Good Agricultural and Collection Practices, Engineering, and Clinical practices to various industries, including Biopharmaceuticals, Pharmaceuticals, Medical Devices, and Medical Cannabis. We work closely with our life sciences clients to assist them in establishing greenfield projects or brownfield projects, guiding them from the project stage through to regulatory approval for their GxP sites. Our involvement spans feasibility assessment, facility and system design review, quality system development, qualification and validation, and regulatory submission support. This end to end approach ensures that compliance is built into the project from the outset rather than addressed after construction or startup.
GxP Cellators is built on the expertise of highly qualified professionals who bring direct industry experience to every engagement. Our team comprises specialists in Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP), Good Agricultural and Collection Practices (GACP), cleanroom operations, and engineering operations.
Our Subject Matter Experts (SMEs) are extensively trained and possess the essential knowledge and skills required to excel in their respective domains. They have worked in manufacturing facilities, analytical laboratories, clinical operations, distribution networks, and engineering projects. This practical background allows them to interpret regulations accurately and translate them into workable solutions for your organization.
We invest in continuous professional development to ensure our team remains current with evolving regulatory expectations. Our consultants hold relevant certifications and maintain active membership in industry associations. They participate in regulatory training, attend industry conferences, and monitor changes in global requirements from Health Canada, FDA, EMA, MHRA, TGA, WHO, and PIC/S.
When you engage GxP Cellators, you work directly with experienced professionals who understand the technical, operational, and regulatory challenges you face. Our team is structured to provide focused expertise for each service area while maintaining the flexibility to assemble cross functional project teams when your needs span multiple domains.
We have subject matter expertise in GMP site readiness programs, including cleanroom validation, equipment and utility qualification, computerized system validation, thermal validation, and cleanroom utilities. Our regulatory affairs team supports submissions across IND, CTA, NDA, BLA, MAA, and CMC, and provides strategic guidance for agency interactions and inspection readiness.
Our services also cover Quality Assurance and Quality Control, including the design and implementation of Quality Management Systems, analytical method validation, and GxP compliance across GMP, GCP, GLP, GDP, GVP, and GACP. We conduct audits for clients and contractual parties, covering internal audits, supplier and vendor qualification audits, contractor audits, and pre approval inspection readiness audits.
For sponsor companies, we provide CMC and CMC QA services, including CMC documentation development, quality assurance review of CMC sections for regulatory submissions, and quality oversight of CDMOs, CMOs, CROs, and third party vendors. Our clinical development support includes GCP compliance, clinical trial application preparation, and pharmacovigilance system support.
Our medical cannabis practice covers GACP and GMP requirements for cultivation, processing, and packaging facilities, including EU GACP certification support and Health Canada Cannabis Regulations compliance.
We tailor our services to meet our clients’ specific needs, which has consistently proven effective and cost-efficient. As a result, our firm has earned a reputation as a premier consulting entity and has become the preferred choice for enterprises seeking exceptional services.
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