Serving the Life Sciences Industry

Consulting expertise in Biopharmaceuticals, Pharmaceuticals, and Medical Devices industries


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Reliable & Analytic

We offer a full range of services in GCP, GLP, and GMP compliance from development through commercialization


Explore Our Services




Accurate & Reliable

Helping clients comply fully with Health Canada, FDA, EMEA, ISO 9001/13485/14644/17025, and WHO regulatory requirements


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At GxP Cellators, we are industry leaders in implementing advanced best practice models, standards and regulations. Our expertise in this area enables us to deliver exceptional value to private and public clients. Our mission-critical approach ensures that we consistently exceed our clients’ expectations and set new industry standards. We take great pride in our reputation for excellence and extend a warm invitation for you to experience it firsthand.

Welcome to GxP Cellators

We offer comprehensive Good x Practices (GxP) services in Manufacturing, Laboratory, Distribution, Engineering and Clinical practices to industries such as Biopharmaceuticals, Pharmaceuticals, and Medical Devices. Our highly qualified experts specialize in GMP, GLP, GCP, GDP, Cleanroom and Engineering operations. We provide expertise in GMP Site-readiness programs, Regulatory Affairs support, Quality Assurance/Control and Clinical Development. Our tailored services have earned us a reputation as a premier consulting entity, making us the preferred choice for enterprises seeking exceptional services.

Our Services

Our unique approach and strategies are one of the most admirable parts of our services. Our professionals are well-versed in the current practices, regulations, and guidelines, which enables them to deliver the desired results with enhanced productivity and minimize business risks.

Cleanrooms Consultants

Commissioning, Qualifications & Validations

We provide a comprehensive suite of services for Commissioning, Qualification, and Validation (CQV) tailored for both greenfield and brownfield

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Cleanrooms Consultants

Cleanroom Commissioning & Qualifications

Our team comprises skilled validation specialists with extensive experience in facility design, layout preparation, and commissioning and validation.

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Cleanrooms Consultants

Engineering

Our team of multi-disciplinary engineers is committed to providing comprehensive support throughout the entirety of the project lifecycle, encompassing conceptual design through

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Cleanrooms Consultants

Project Management

We provide a comprehensive suite of project management services, facilitated by proficient project management coordinators and PMP-certified project managers. Our team is equipped

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Cleanrooms Consultants

Quality Support

We design a robust quality management system per our client’s needs. We offer a full range of services in GLP, GCP, and GMP compliance from development through commercialization.

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Cleanrooms Consultants

Regulatory Support

Leverage our years of experience working with Health Canada to navigate and expedite your company’s Canadian regulatory affairs program. Leverage our years of experience

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What our customers are saying about us

We have had the privilege of partnering with GxP Cellators for the past five years, during which time they have provided invaluable oversight of our quality and regulatory programs. Their expertise was instrumental in setting up our parent manufacturing site, which currently meets FDA and Health Canada-GMP standards. We are pleased to report that GxP Cellators is now assisting us in establishing a second manufacturing site that will generate GMP-grade CBD Isolates for clinical use. This is an exciting development for our research, and we are grateful for the continued support of GxP Cellators in this endeavour.

CEO & President, Pharmaceutical Company CDMO

We engaged GxP Cellators to assist us with preparing for an FDA Inspection, and we could not have been more impressed with their services. The team demonstrated a high degree of diligence and thoroughness, ensuring that all of our documentation was in order and that all necessary CAPAs had been implemented. Additionally, they took the time to provide invaluable coaching to our staff on CAPAs and interview techniques. We found the consultants to have an impressive range of skills and knowledge, which proved immensely beneficial to our organization. Overall, we highly recommend GxP Cellators to organizations seeking professional and effective assistance preparing for regulatory inspections.

SVP Clinical Development, Biopharmaceutical Company

We received excellent assistance from GxP Cellators in creating the CSV documentation necessary for validating computerized systems such as NovaLimbs, e-QMS Vault, and the ERP system. The consultants we worked with were highly knowledgeable about recent regulatory requirements and were proactive in keeping us informed. GxP Cellators completed the project well within the agreed-upon timeline. Overall, we were delighted with their work.

VP of I.T., Drug Development Company “Chemo-Space”

GxP Cellators oversees the quality and regulatory operations of our GMP-transition project. They designed the required quality management system and validation documentation for Phase 1 and we’re now in Phase 2. The project is going smoothly. Great job, GxP Cellators team!

CEO & CSO, Pharmaceutical CDMO

Our organization contracted GxP Cellators for technical writing services on laboratory investigations, which helped us close open cases promptly with expert technical and regulatory advice. We signed a multi-year contract with GxP Cellators for regular quality support and staff mentoring on regulatory standards.

President, Biotechnology Startup-CDMO

The expertise of GxP Cellators was instrumental in facilitating our site readiness programs. Their contributions included the design of site validation documentation and the development of regulatory strategies for our manufacturing operations. The team’s professionalism and focus on results were highly commendable and contributed to the successful completion of our program. We wholeheartedly endorse GxP Cellators and their services.

Director of Laboratory Operations, Biotechnology CDMO

Our experience with GxP Cellators has been highly positive. The team at GxP Cellators provided us with invaluable assistance in redesigning our Quality Management System (QMS), which proved instrumental in successfully submitting our class-III medical devices application to the regulatory body. Throughout the QMS redesign process, we were introduced to a team of highly competent and experienced consultants who approached our project with the utmost diligence and professionalism. Their proactive approach enabled us to establish the necessary standard and obtain the ISO 13485 certification, which was crucial in gaining approval for our class III medical devices. We are grateful for the expertise and guidance provided by GxP Cellators and would highly recommend their services to other organizations needing similar assistance.

CTO, Medical Device Company

Our Blogs

Media Fill

Media Fill: A Critical Validation Process in Aseptic Manufacturing

Media Fill: A Critical Validation Process in Aseptic Manufacturing What is Media Fill? A Media Fill, also known as a…

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products (ATMPs)

Advanced Therapy Medicinal Products (ATMPs) are an emerging class of medicines based on genes, cells, or tissues that offer revolutionary…

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GCP QMS

GCP QMS: Quality Management System for Sponsor Companies

A Good Clinical Practice Quality Management System (GCP QMS) is a structured framework that ensures sponsor companies maintain compliance with…

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Clean and Dirty Utilities

Clean and Dirty Utilities in Biologics Projects

Clean and Dirty Utilities in Biologics Projects Clean Utilities These utilities come into direct or indirect contact with the product,…

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Biosafety Cabinets

Biosafety Cabinets

Biosafety Cabinets: Why Are They Required? Biosafety Cabinets (BSCs) are essential engineering controls in laboratories that handle potentially infectious agents…

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Equipment Qualifications

Analytical Instrument and System Qualification (AISQ)

Purpose USP <1058> provides a scientific and risk-based framework for the qualification of analytical instruments and systems to ensure they…

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Medical Devices License

Medical Devices License I MDL I MDEL

In Canada, Health Canada regulates medical devices, ensuring their safety, effectiveness, and quality. The primary legislation governing medical devices is…

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Cleanroom documentation

Cleanroom Documentation

The Cleanroom Documentation Package (CDP) is a critical set of documents that ensures cleanrooms meet industry standards and regulations for…

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GMP Auditing Services

GMP Auditing Services I GMP Audits I GMP Auditors

GMP auditing is an essential process that ensures companies adhere to Good Manufacturing Practices. These practices are critical for maintaining…

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Cleanroom URS

User Requirements Specification (URS) for the Cleanrooms

A User Requirement Specification (URS) is a critical document for designing, constructing, and validating a cleanroom. It outlines the specific…

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Cell and Gene Therapy

Revolution in Cell and Gene Therapy

The cell and gene therapy revolution represents a groundbreaking shift in medicine, providing new avenues for the treatment and potential…

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Good Distribution Practices

Good Distribution Practices (GDP) Certification

Good Distribution Practices (GDP) Certification: Good Distribution Practices (GDP) ensure that pharmaceutical products are consistently stored, transported, and handled following…

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Biologics

Cleanroom panels for biologics facilities

Cleanroom panels for biologics facilities are critical to maintaining the necessary environmental conditions to produce, store, or handle biologics products….

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HPLC Qualification

Qualifications and Validations of Chromatographic Systems: HPLC I UPLC I LC-MS

Qualifications and Validations of Chromatographic Systems: HPLC I UPLC I LC-MS Why is the qualification of laboratory equipment necessary? Qualifying…

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Quality Control Laboratory Setup

Quality Control (QC) Laboratory Setup in Pharmaceuticals and Biologics Industries I QC Setup I QC Setup Consultants

Quality Control (QC) Laboratory is critical in ensuring pharmaceutical and biologic products' safety, efficacy, and quality. It encompasses systematic activities…

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GLP Consultants

Bioanalytical GLP Consultants

Bioanalytical GLP Consultants Bioanalytical GLP consultants are professionals who provide guidance, support, and expertise to organizations that need to comply…

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Cleanroom smoke studies

Cleanroom Smoke Studies

Cleanroom smoke studies are critical to assessing the airflow, cleanliness, and overall performance of controlled environments such as cleanrooms. Contamination…

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HVAC HVAC System

Air Handling Unit (AHU)

An Air Handling Unit (AHU) is vital to HVAC (Heating, Ventilation, and Air Conditioning) systems. Its primary responsibility is to…

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Biologics Site Layouts

Biologics Site Layouts

Designing a biologics facility involves creating a layout and process flow that ensures biologic products' safe, efficient, and compliant production….

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GMP Remediation Projects

GMP Remediation Projects

GMP (Good Manufacturing Practice) remediation projects refer to efforts undertaken by pharmaceutical or biotechnology companies to bring their facilities, systems,…

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Quality Policy

GxP Cellators is committed to upholding the highest quality standards in its services. We are fully dedicated to meeting all applicable regulations, statutory requirements, and customer specifications, ensuring our clients receive the best possible service.

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