Serving the Life Sciences Industry

Consulting expertise in Pharmaceuticals, Medical Devices, Biologics, and Cannabis 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 take pride in our expertise in implementing advanced best practice models, standards, and regulations. This enables us to deliver exceptional value to our clients, both in the private and public sectors. Our mission-critical approach ensures that we always go above and beyond to meet our clients’ needs and exceed their expectations.

Welcome to GxP Cellators

GxP Cellators is a one-stop consulting company that provides quality and regulatory services to the pharmaceutical, biopharmaceutical, medical devices, and cannabis industries. For every need, we have different teams of experts that are educated and qualified to reflect their superiority in work.
From product development and submissions to company-wide change management, we design, implement, and run quality, results-focused outcomes for everyone we work with.
Our expert subject matter knowledge of regulatory affairs, quality assurance/control, and clinical development ensure we deliver results that matter. Our focused approach to providing real time and customized services to our clients has proven to be both effective and cost-efficient.

Our Services

Our unique approach and strategies are one of the most admirable parts of our services. Our professionals are knowledgeable with the current practices, regulations and guidelines that help them deliver the result with enhanced productivity along with ensuring no business risks.

Cleanroom Commissioning and Qualifications

Our team includes validation specialists with extensive expertise in facility designing, facility layout preparations, and commissioning and validation


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.


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 working with Health Canada


Our Blogs

Our expert subject matter knowledge of regulatory affairs, quality assurance/control, and clinical development ensure we deliver changes that matter. Our focused approach to providing real time and customized services to our clients has proven to be both effective and cost-efficient.

Computerized System Validations

Computerized System Validation: Navigating the Regulatory Landscape

Computerized System Validation (CSV) is a critical process in the life sciences and pharmaceutical industries to ensure that computerized systems,…
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Computerized System Validations Life Sciences & Technology Medical Devices

Computerized systems: Designing a well-structured privileges matrix for computerized systems

Designing a privileges matrix for computerized systems is a critical process that involves defining and assigning access rights to different…
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Cleanrooms GMP Site Layouts

HVAC Systems: Requirements and significance in the life sciences industry

The HVAC (Heating, Ventilation, and Air Conditioning) systems in the life sciences industry play a critical role in maintaining the…
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GMP Site Layouts Validations

Designing GMP facilities? Consider layout, equipment, materials, personnel, and quality control.

Designing a pharmaceutical manufacturing site layout involves careful planning to ensure efficiency, compliance with regulatory standards, and a safe working…
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Medical Devices quality management system

Medical Devices: The categories and the regulatory landscape

Medical devices encompass a wide range of products designed to diagnose, monitor, treat, or alleviate medical conditions. The regulatory landscape…
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CMC pharmaceutical development pharmaceutical quality resources quality management system

The Pathway for Cancer Drug Development

Chemotherapy is a form of cancer treatment that uses drugs to destroy or inhibit the growth of cancer cells. The…
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Auditing pharmaceutical quality resources quality management system Validations

Ensure accurate data with Excel sheet validations

In the pharmaceutical industry, data accuracy and compliance with regulatory standards are of utmost importance. Excel sheet validations play a…
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GMP Life Sciences & Technology quality management system

Data Integrity in the Life Sciences Industry “Components and the Regulatory Expectations”

Data integrity is an essential aspect of ensuring the accuracy, reliability, and consistency of data across various fields, including the…
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Internal Auditing: Significance and the Regulatory Expectations

Internal auditing is a crucial component of the pharmaceutical industry that is responsible for ensuring compliance with regulations, maintaining product…
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Biological Intermediates: The Regulatory Expectations

Biologics intermediates are life-saving products that can vastly improve patients’ quality of life. As such, regulatory agencies must ensure their…
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Quality by Design (QbD): A systematic approach to drug development

The Quality by Design (QbD) approach is gaining more significance during the drug development process. This comprehensive and proactive approach…
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Sterile manufacturing: Cleanroom gowning process

Cleanroom gowning involves wearing specialized clothing to enter and work in an environment that has been specially designed to minimize…
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Cleanrooms GMP Life Sciences & Technology

Cleanroom behaviors

Cleanroom behaviours refer to the practices and protocols followed in environments where cleanliness and contamination control are critical, such as…
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Cleanrooms: Commissioning and Qualifications

Cleanroom qualification requirements refer to the processes and criteria used to ensure that a cleanroom facility meets the necessary standards…
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In the pharmaceutical industry, “out of trend” typically refers to a situation where data or test results deviate from established…
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Site Master File

A Site Master File (SMF) is a document prepared by a pharmaceutical company to provide detailed information about a specific…
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Biologics: complex production, crucial for treatment.

Biologics manufacturing presents several challenges due to the complex nature of biological products. These challenges encompass various stages of production,…
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Auditing GMP Life Sciences & Technology pharmaceutical quality resources

Quality Auditing: A Deep Dive into Ensuring Excellence

Quality is paramount in any business. It signifies trustworthiness, reliability, and consistency. Without a defined measure of quality, products or…
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pharmaceutical quality resources

The Significance of Quality Assurance

Quality assurance (QA) in pharma is the process of ensuring that pharmaceutical products meet or exceed quality standards. This includes…
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GMP Regulations in Different Countries | Comprehensive Overview

Good Manufacturing Practices (GMP) are a set of guidelines and regulations that ensure the quality, safety, and efficacy of pharmaceuticals,…
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Quality Policy.

GxP Cellators is commited excellence in meeting the quality of its services as per applicable regulations, statutory requirements and customer specification.

If you have any questions, please feel free to ask

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We’re here to help answer your questions. Send us a brief description of your query in full confidentiality and an experienced consultant in the field you’re inquiring about will get in touch with you shortly after.

    Our Presence

    Saskatchewan, CanadaFrankfurt, Germany

    Toronto, CanadaNorth Carolina, USA

    Indiana, USACalgary, Canada