GMP · GLP · GCP · GDP · GVP · GACP Highly qualified experts
About GxP Cellators
Expert GxP Compliance Consultants for Life Sciences
GxP Cellators is a specialized consulting firm focused on the implementation of advanced best practice models, standards, and regulations. Our expertise enables us to deliver measurable value to both private and public sector clients. We maintain a mission critical approach to ensure client expectations are consistently met and industry standards are upheld. We provide Good x Practices (GxP) services across Manufacturing, Laboratory, Distribution, Pharmacovigilance, Good Agricultural and Collection Practices for medical cannabis, Engineering, and Clinical practices. Our client base includes organizations within the biopharmaceutical, pharmaceutical, medical device, and medical cannabis sectors, as well as sponsor companies requiring CMC and CMC QA support. Our consultants specialize in GMP, GLP, GCP, GDP, GVP, GACP, cleanroom operations, and engineering. Our core services are GxP auditing, quality management system design and support, CMC and CMC QA services for sponsor companies, regulatory affairs support, commissioning, qualification, and validation, cleanroom commissioning and qualification, and project management. We also support capital projects through our CQV services where clients require integrated engineering and compliance delivery. Our tailored service model has established us as a preferred consulting partner for enterprises seeking rigorous compliance support.
- Health Canada
- FDA
- EMEA
- WHO
- ISO 9001
- ISO 13485
- ISO 14644
- ISO 17025
- GMP
- GLP
- GCP
- GDP
What we do
OUR SERVICES
GxP Auditing
GxP Cellators is recognized for delivering rigorous, independent, and regulator aligned auditing services. Our auditors are seasoned professionals with direct experience across manufacturing, laboratory, distribution, pharmacovigilance, and clinical operations. We evaluate your systems, documentation, facilities, and personnel against applicable regulatory requirements to identify deficiencies before a regulator does. Our audit practice is built on deep technical expertise, practical remediation experience, and a clear understanding of what inspectors look for.
- Audit Types: Internal audits, supplier audits, vendor qualification audits, contractor audits, pre approval inspection readiness audits, for cause audits, and due diligence audits for acquisitions and partnerships.
- Standards Covered: GMP, GLP, GCP, GDP, GVP, GACP, and ISO 9001, ISO 13485, ISO 14644, ISO 17025.
- Deliverables: Audit reports, risk ranked gap assessments, corrective and preventive action (CAPA) plans, remediation roadmaps, and follow up verification audits.
- Regulatory Alignment: Health Canada (HPFBI, GMP, GLP, GCP, GDP, GVP, GACP), US FDA (21 CFR Parts 210, 211, 312, 820), EU EudraLex Volume 4 (GMP), Volume 10 (Clinical Trials), EMA GVP modules, MHRA Orange Guide, TGA Therapeutic Goods Act, and PIC/S GMP Guide.
- Medical Cannabis Specific: Health Canada Cannabis Regulations, EU GACP guidelines, and GMP requirements for cannabis cultivation and processing.
- Sponsor Company Support: Audits of CROs, CDMOs, CMOs, and third party service providers on behalf of sponsor companies, including qualification audits and ongoing oversight audits.
Quality Support
We design, implement, and maintain quality management systems that align with client specific requirements. Our services span GLP, GCP, GMP, GDP, GVP, and GACP compliance, covering the full lifecycle from development through to operational audits. We also provide dedicated quality support for sponsor companies, including CMC and CMC QA services.
- QMS Design and Implementation: Quality manuals, standard operating procedures (SOPs), work instructions, and quality policies.
- Document Control: Drafting, review, approval, and lifecycle management of controlled documents.
- Deviation and CAPA Management: Investigation support, root cause analysis, and effectiveness checks.
- Change Control: Assessment of proposed changes for regulatory impact and implementation planning.
- Training Program Development: Role based curricula and competency assessment frameworks.
- Supplier and Vendor Qualification: Quality agreements and supplier oversight programs.
- Sponsor Company Quality Support: Quality oversight of CDMOs, CMOs, CROs, and third party vendors on behalf of sponsor companies. This includes quality agreements, batch record review, deviation and CAPA oversight, release support, and vendor qualification.
- CMC Services: Chemistry, Manufacturing, and Controls documentation, including drug substance and drug product specifications, analytical method descriptions, stability protocols, manufacturing process descriptions, and regulatory submission content for IND, NDA, BLA, and MAA filings.
- CMC QA Services: Quality assurance review of CMC documentation, batch records, analytical data, and release packages. This includes GMP compliance review of CMC sections for regulatory submissions, data integrity checks, and alignment with ICH Q2, Q3, Q6, Q7, and Q8 requirements.
- Regulatory Alignment: Health Canada GMP guidelines, US FDA 21 CFR Part 211, EU GMP Annex 11 (computerised systems), ICH Q7 (API), ICH Q9 (quality risk management), ICH Q10 (pharmaceutical quality system), and ISO 9001 and ISO 13485 quality management principles.
- Medical Cannabis Specific: Health Canada Cannabis Regulations, EU GACP quality requirements, and GMP requirements for cannabis processing and packaging.
Regulatory Support
We apply our experience with Health Canada and other global regulators to help clients navigate and expedite regulatory affairs programs. Our support includes streamlined filing preparation and regulatory strategy development.
- Regulatory Strategy: Pre submission planning and agency interaction support.
- Submission Preparation: Drug establishment licences (DEL), medical device licences (MDL), site licence applications, and cannabis licences.
- Health Canada Liaison: Meeting preparation and response to information requests.
- FDA and EMA Support: Pre IND, IND, NDA, BLA, MAA, and 510(k) submission assistance.
- Regulatory Intelligence: Monitoring of changing requirements and impact assessment.
- Inspection Readiness: Mock inspections and front room and back room support.
- Regulatory Alignment: Health Canada Food and Drugs Act, Cannabis Act and Regulations, US FDA Federal Food, Drug, and Cosmetic Act, EU EudraLex Volume 1 (pharmaceutical legislation) and Volume 2 (notice to applicants), MHRA Human Medicines Regulations, TGA Therapeutic Goods Act, and WHO guidelines.
- Medical Cannabis Specific: Health Canada Cannabis Act, Cannabis Regulations, and EU GACP certification requirements.
Commissioning, Qualifications and Validations (CQV)
We provide Commissioning, Qualification, and Validation (CQV) services for both greenfield and brownfield facility environments. Our deliverables are structured to meet regulatory expectations for equipment and system qualification. Where clients require integrated project delivery, we also support capital projects through our CQV services, managing the validation and qualification scope from concept through to operational handover.
- Commissioning: Factory acceptance testing (FAT), site acceptance testing (SAT), and commissioning documentation.
- Qualification: Design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Process Validation: Process design, process qualification, and continued process verification.
- Cleaning Validation: Sampling strategies, acceptance criteria, and recovery studies.
- Computer System Validation (CSV): GAMP 5 based validation and 21 CFR Part 11 compliance.
- Analytical Method Validation: Method development, qualification, and transfer.
- Turnkey CQV Program Management: Master validation planning, protocol development, execution oversight, and final report generation for new facilities and major modifications.
- Regulatory Alignment: Health Canada GMP guidelines (C.02.015 to C.02.029), US FDA 21 CFR Part 211 (equipment and validation), EU GMP Annex 15 (qualification and validation), EU GMP Annex 11 (computerised systems), EU GMP Annex 1 (sterile products), ICH Q2 (analytical validation), ICH Q7 (API), ISPE Baseline Guides, and ASTM E2500 (commissioning and qualification).
- Medical Cannabis Specific: Health Canada Cannabis Regulations, EU GACP requirements for facility and equipment, and GMP validation requirements for cannabis processing.
Cleanroom Commissioning and Qualifications
Our validation specialists possess extensive experience in cleanroom facility design, layout preparation, and ISO standard commissioning. We support clients in achieving and maintaining compliant cleanroom environments.
- Design Review: Layout assessment and contamination control strategy.
- Commissioning: HVAC balancing, air change rate verification, and pressure differential mapping.
- Qualification: ISO 14644 classification, recovery testing, and airflow visualization.
- Environmental Monitoring: Viable and non viable monitoring program design.
- Personnel and Material Flows: Gowning qualification and material transfer procedures.
- Regulatory Alignment: EU GMP Annex 1 (manufacture of sterile medicinal products), US FDA aseptic processing guidance, ISO 14644 Parts 1 and 2 (cleanroom classification and testing), ISO 14698 (biocontamination control), Health Canada GMP guidelines, and PIC/S PI 007 (sterile products).
- Medical Cannabis Specific: Health Canada Cannabis Regulations, EU GACP cleanroom requirements, and GMP cleanroom standards for cannabis processing.
Project Management
We provide project management services facilitated by proficient project coordinators. Our coordinators ensure timely delivery of compliance deliverables while maintaining adherence to regulatory requirements.
- Project Planning: Scope definition, resource allocation, and timeline development.
- Stakeholder Coordination: Cross functional team facilitation and communication management.
- Risk Management: Identification, assessment, and mitigation planning.
- Progress Tracking: Milestone reporting and deliverable status updates.
- Budget Oversight: Cost tracking and variance reporting.
- Documentation Control: Project records and regulatory submission support.
- Regulatory Alignment: ICH Q10 (pharmaceutical quality system), ISO 9001 (quality management), and PMI Project Management Body of Knowledge (PMBOK).
- Medical Cannabis Specific: Health Canada Cannabis Regulations project requirements and EU GACP project documentation standards.
Testimonials
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.
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.
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.
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!
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.
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.
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.
Training
Our GxP Training Services
GxP Cellators specializes in delivering Good Manufacturing Practice (GMP) training aligned with the evolving compliance needs of life sciences organizations. Our training programs are structured to ensure personnel competency and regulatory awareness across all GxP disciplines.
Cleanroom Trainings
Our customizable Cleanroom Training aligns with ISO 14644, EU GMP, and US FDA guidelines. Programs are offered both on site and virtually.
- Topics covered: Cleanroom classification, gowning and aseptic technique, environmental monitoring, and contamination control.
- Delivery formats: On site instructor led, virtual instructor led, and e learning modules.
- Assessment: Competency testing and certification upon completion.
- Regulatory alignment: EU GMP Annex 1, ISO 14644, ISO 14698, US FDA aseptic processing guidance, and Health Canada GMP guidelines.
GMP Trainings
We offer customized GMP training programs aligned with US FDA, EU GMP, Health Canada, TGA, MCC, MHRA, and PIC/S standards.
- Topics covered: GMP fundamentals, data integrity, deviation handling, CAPA, change control, and documentation practices.
- Role specific programs: Manufacturing operators, quality assurance, quality control, and warehouse personnel.
- Delivery formats: On site, virtual, and blended learning.
- Certification: Certificate of completion issued for all participants.
- Regulatory alignment: US FDA 21 CFR Parts 210 and 211, EU EudraLex Volume 4, Health Canada GMP guidelines, TGA Therapeutic Goods Act, MCC South African GMP, MHRA Orange Guide, PIC/S GMP Guide, and ICH Q7 and Q10.
GDP Trainings
Our GDP training programs meet global standards, including Health Canada, EU GMP, US FDA, TGA, MCC, MHRA, and WHO requirements.
- Topics covered: Temperature controlled distribution, cold chain management, transport qualification, and warehouse operations.
- Regulatory alignment: Health Canada GDP guidelines, EU GDP guidelines (2013/C 343/01), US FDA 21 CFR Part 211 (distribution), WHO TRS 957 Annex 5 (GDP for pharmaceutical products), TGA GDP guidelines, and MHRA GDP guidance.
- Delivery formats: On site and virtual instructor led sessions.
- Assessment: Knowledge checks and post training evaluation.
GVP Trainings
Our GVP training programs address pharmacovigilance requirements for marketed products and investigational medicinal products.
- Topics covered: Adverse event reporting, signal detection, risk management plans, periodic safety update reports (PSURs), and pharmacovigilance system master file (PSMF).
- Regulatory alignment: EU GVP Modules I through XVI, US FDA 21 CFR Part 312 and 314 (IND and NDA safety reporting), Health Canada Pharmacovigilance requirements, ICH E2A, E2B, E2C, E2D, and E2E, and WHO pharmacovigilance guidelines.
- Delivery formats: On site and virtual instructor led sessions.
- Assessment: Case study exercises and competency evaluation.
GACP Trainings
Our GACP training programs support medical cannabis cultivators, processors, and distributors in meeting Good Agricultural and Collection Practice requirements.
- Topics covered: Cultivation site selection, seed and plant material management, pest control, irrigation and fertilization, harvest and post harvest handling, drying and storage, personnel hygiene, and documentation.
- Regulatory alignment: Health Canada Cannabis Regulations, EU GACP guidelines (EMEA/HMPC/246816/2005), WHO GACP guidelines, and GMP requirements for cannabis processing.
- Delivery formats: On site and virtual instructor led sessions.
- Assessment: Knowledge checks and practical demonstration evaluation.
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.
Contact
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Expert GxP Compliance Consultants for Life Sciences – GMP, GLP, GCP, GDP and ISO services for pharmaceutical, biopharmaceutical and medical device companies.
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Our Presence
- Saskatchewan, Canada
- Calgary, Canada
- Toronto, Canada
- North Carolina, USA
- Frankfurt, Germany
- Indiana, USA
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