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


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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

GxP Cellators is a reputable consulting firm that offers quality and regulatory services to various industries, including pharmaceuticals, biopharmaceuticals, medical devices, and cannabis. The company retains a team of highly qualified experts who possess the requisite knowledge and skills necessary to excel in their respective fields. GxP Cellators distinguishes itself by providing exceptional services in product development, submissions, and company-wide change management. Their extensive subject matter expertise in regulatory affairs, quality assurance/control, and clinical development ensures that they deliver relevant and valuable outcomes. Furthermore, GxP Cellators customizes its services to meet clients’ specific needs, and this approach has proven effective and cost-efficient. As such, the company has earned a reputation as one of the leading consulting firms, and it is a preferred choice for businesses 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.


Cleanroom Commissioning and Qualifications

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

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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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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

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What our customers are saying about us


CEO & President, Pharmaceutical Company CDMO

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.

SVP Clinical Development, Biopharmaceutical Company

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.

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

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.

CEO & CSO, Pharmaceutical CDMO

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!

President, Biotechnology Startup-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.

Director of Laboratory Operations, Biotechnology 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.

CTO, Medical Device Company

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.

Our Blogs

Our team’s extensive expertise in regulatory affairs, quality assurance/control, and clinical development allows us to make impactful changes. By offering tailored and timely services to our clients, we have been able to deliver effective and cost-efficient solutions.

Uncategorized

USFDA Inspections: What You Need to Know as a New Business Owner

The U.S. Food and Drug Administration (FDA) conducts various types of inspections to ensure compliance with regulations governing food, drugs,…
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Cleanrooms GMP Life Sciences & Technology pharmaceutical development Pharmaceutical Packaging pharmaceutical quality resources

Understanding the Details of Process Simulation for Regulatory Compliance

Process simulation, also referred to as media fill, is an essential component of pharmaceutical manufacturing that assesses a facility’s aseptic…
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pharmaceutical quality resources quality management system

Beyond Compliance: How to Use QMS to Drive Business Growth and Success

An effective Quality Management System (QMS) is crucial for organizations to ensure that their products and services meet or exceed…
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Cleanrooms GMP Life Sciences & Technology

Why Validation is Key to Safe and Effective Pharmaceutical Site Layouts

Validating pharmaceutical site layouts is crucial to ensure compliance with regulatory requirements, adherence to industry standards, and creating a user-friendly…
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Computerized System Validations CQV GMP Life Sciences & Technology pharmaceutical quality resources quality management system Site Layouts

The Evolution of Life-Sciences Site Commissioning and Validation: Past, Present, and Future

The commissioning and validation of life sciences sites have evolved significantly over the years due to technological advancements, regulatory requirements,…
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Uncategorized

Factors to Consider When Designing a Cleanroom Facility

Designing a cleanroom facility requires careful consideration of various factors to ensure a controlled environment with minimal contaminants. Here are…
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Cleanrooms GMP

Compressed Gases: Qualifications and the Regulatory requirements

The U.S. Food and Drug Administration (USFDA) sets regulatory requirements for various aspects of the pharmaceutical industry, including the qualification…
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Cleanrooms GMP pharmaceutical quality resources Site Layouts

Cleanroom validations for aseptic manufacturing

Validation of cleanrooms for aseptic manufacturing is crucial to ensuring the quality and safety of pharmaceutical and biopharmaceutical products. Aseptic…
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Life Sciences & Technology pharmaceutical quality resources quality management system Site Layouts

The Art of Crafting a Comprehensive Validation Plan for Life Sciences Site Utilities

Crafting a comprehensive validation plan for life sciences site utilities requires careful planning and execution. It is important to ensure…
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Uncategorized

The commissioning process for Heating, Ventilation, and Air Conditioning (HVAC) systems

The commissioning process for Heating, Ventilation, and Air Conditioning (HVAC) systems involves a series of steps to ensure that the…
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Cleanrooms GMP

Aseptic process simulation (APS)

Aseptic process simulation (APS) is a critical component of the validation process in pharmaceutical manufacturing, particularly in the production of…
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Computerized System Validations

The Future of Scientific Research: Electronic Notebooks and User Validation

Validating electronic notebooks is a crucial step in ensuring the integrity, reliability, and compliance of data recorded in a digital…
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CMC

From Bench to Bedside: The Importance of Technology Transfer in Advancing Healthcare

The process of technology transfer involves the transfer of knowledge, technology, and intellectual property between organizations or individuals. In the…
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Computerized System Validations

SaaS Compliance: How to Stay Ahead of the Game

Software as a Service (SaaS) providers have a responsibility to ensure the security, privacy, and legality of their services by…
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quality management system

“Quality Policy-Significance in the life sciences industry”

In the life sciences industry, a quality policy holds significant importance as it serves as a foundational document that outlines…
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CMC GMP Stability

Stability Programs: Biologics vs Pharmaceuticals

Stability programs are crucial components of the drug development process, ensuring the quality, safety, and efficacy of pharmaceutical products over…
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Pharmaceutical Packaging

The Art of Container Selection: How to Choose Containers That Fit Your Needs

Selecting primary containers for pharmaceutical packaging is a critically important task that necessitates careful attention to a multitude of factors,…
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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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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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    Saskatchewan, CanadaFrankfurt, Germany

    Toronto, CanadaNorth Carolina, USA

    Indiana, USACalgary, Canada