Quality engineering impacts all product basics, processes and structures. Choose GQC to ensure that your facility meets your business goals, integrating solutions that have a low environmental impact wile remaining profitable and fully compliant with the latest engineering and international best practices, always keeping sustainable solutions in mind.

  • list-icon Trimming, drying and packaging departments
  • list-icon Extraction and post processing departments
  • list-icon CBD isolate and full spectrum plants
  • list-icon Value Stream Mapping
  • list-icon HVAC System and Utilities
  • list-icon Energy management
  • list-icon Construction Supervision
  • list-icon Overall Equipment Efficiency (OEE) optimization programs
  • list-icon Site Master Plan
  • list-icon Procurement Support and cost estimation
  • list-icon Risk Assessment and Validation service (FAT, SAT, IQ, OQ, PQ)
  • list-icon Professionals who provide support and train your staff
  • list-icon Implementation of new tech components and processes in downstream workflow
  • list-icon We support you on the right choice of equipment and its provider
  • list-icon Revamping solutions for existing departments and facilities in compliance with GACP and GMP regulations
  • list-icon Partial or full facility reconstruction plan optimizing output and reducing costs

GxP Quality Compliance

For Life Science businesses in highly regulated environments,
compliance is not an option. Prepare to successfully pass audits and inspections for your product with GQC’s tailored and cost-effective programs for Quality Management.

  • list-icon Quality system documentation hierarchy design
  • list-icon Workflow definition & Standard template alignment
  • list-icon Draft procedures with reference applicable standards (GACP, GLP, GCP, GMP, PIC/s, ICH Guidelines etc.)
  • list-icon Inspection Readiness and on site support
  • list-icon Process Validation
  • list-icon Risk Analysis Management
  • list-icon Analytical Method Development and Validation
  • list-icon Cleaning Validation
  • list-icon GxP and ISO certified quality system application
  • list-icon A Global network of local auditors ready to execute audits worldwide operating from PQE subsidiaries and offices
  • list-icon Remote audits whenever on-site audits are not allowed due to restrictions
  • list-icon QMS implementation
  • list-icon QA outsourcing support
  • list-icon GCP Auditing
  • list-icon GCP Inspection readiness

Regulatory Affairs

Our service begins with the development of the regulatory strategy and is concluded with editing, amendment and submission of the necessary documents needed for authorization request. Provided by the expertise of our consultants, fully electronic submissions for the EU, USA, Canada, Switzerland, along with paper submissions are handled in the fastest and most professional manner, while ensuring that dossiers are compliant to the strictest regulations.

  • list-icon Reach any country, assuring dedicated coverage leveraging on PQE group global office network
  • list-icon Up-to-date local and global regulatory status and requirements review
  • list-icon Preparation of necessary documentation for regulatory bodies according to current requirements
  • list-icon Dossier compilation and publishing
  • list-icon Manage products’ approval and registration
  • list-icon Improvement and standardization of regulatory processes
  • list-icon Preparation of product registration documents
  • list-icon Final product release specifications
  • list-iconAssemble and collect all the Administrative, Technical, Quality, Safety information in a common format (CTD)
  • list-iconSupport for the CTD submission process according to the current regulations and requirements of the country
  • list-iconSubmit correct classification and grouping of variation in order to reduce time and effort
  • list-iconImplementing any required changes in order to keep the CTD up to date
  • list-iconSupport for the renewal of the Marketing Authorization

Scientific Advisory

All-around support with R&D Feasibility Studies for designing and producing new chemical entities, biological products, and generics/ biosimilars. Based on our consolidated expertise we can provide specialized support to best address the high-quality development of therapeutic products.
  • list-icon Specification of precise plant attributes needed
  • list-icon Mapping of alternative hybrids and genetics aspects meeting your specific project goals
  • list-icon Crossbreeding studies and strategic planning
  • list-icon Isolation, identification and biosynthesis of cannabinoids
  • list-icon GACP compliance
  • list-icon Cultivation strategy
  • list-icon Seeds and plants handling
  • list-icon Cultivation & environmental conditions
  • list-icon Plant protection
  • list-icon Harvest conditions & techniques
  • list-icon Drying process
  • list-icon Packaging & storage
  • list-icon Cultivation and post-harvest costs reduction/yield improvements
  • list-icon Scientific and clinical research support
  • list-icon Ongoing research assessment & troubleshooting
  • list-icon Alternative hybrids R&D (Third-party Lab)
  • list-icon Providing the structure and the experts to meet your demands
  • list-icon Third-party pharma study with Lab trial support
  • list-icon High quality product development support
  • list-icon Product development
  • list-icon Choosing the right extraction method that suits the scope of customer’s project
  • list-icon Extraction facility planning and safety requirements
  • list-icon Extraction validation
  • list-icon Process optimization

Clinical Studies

GQC also supports all stakeholders involved — Sponsor, Hospitals, Clinical Sites and Central Labs — in the operation management of clinical studies (observational and interventional Phase I-II) with prospective or retrospective data collection on clinical chart or data base related to medical cannabis products.

  • list-icon Investigator Brochure
  • list-icon Study protocol
  • list-icon Informed Consent
  • list-icon Study report
  • list-icon IMPD
  • list-icon Project Management
  • list-icon TMF management
  • list-icon Site Monitoring
  • list-icon Investigational product management
  • list-icon Set up and validation of the eCFR
  • list-icon Data management Plan
  • list-icon Data cleaning & Database lock
  • list-icon Statistical Analysis Plan and Report
  • list-icon Statistical analysis set up, validation and running
  • list-icon Collection and submission of Clinical Trial Application initial and life cycle management
  • list-icon Clinical Observational studies submission to Competent Authorities and Ethical Committee
  • list-icon Drug Safety management

GQC Academy

GQC Acadmy’s goal is to promote and support education and training in Medical Cannabis both to the stakeholders that are already working in the field, and to those intending to enter it.

A digital platform for your company courses. Ideal for onboarding procedures, standards practice and continuous improvement.

Access engaging online classes and get coached by our globally recognized experts while gathering in-depth focus on critical and relevant topics.

A classic F2F model for training on new regulatory trends and annual updates.

  • list-icon Drug Prescription
  • list-icon Medical Cannabis Product Information
  • list-icon Clinical Data
  • list-icon Drug Administration
  • list-icon Therapeutic Potential Strategies


Keep your investment under control with the help and guidance of our team of experts, specialized in Regulatory and Compliance solutions.