GxP Cellators is a distinguished contract services organization that offers comprehensive Good x Practices (GxP) services in Manufacturing, Laboratory, Distribution, Engineering, and Clinical practices to various industries, including pharmaceuticals, biopharmaceuticals, medical devices, and cannabis. We work closely with our esteemed life sciences clients to assist them in establishing greenfield projects or brownfield projects, guiding them from the project stage to regulatory approval for their GxP sites.
Our team comprises highly qualified experts specializing in Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), 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.
We have profound subject matter expertise in GMP Site-readiness programs such as Cleanroom Validations, Equipment Utility Qualifications, Computerized System Validations, Thermal Validations, and Cleanroom Utilities, as well as Regulatory Affairs support for submissions like IND/CTA/BLA/CMC. Our services also cover Quality Assurance/Control, including designing Quality Management Systems and providing support for Analytical method validation, GxP Compliance related to GMP, GCP, GLP, GDP audits for clients or contractual parties, and Clinical Development.
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.