Services

Engineering

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

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
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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

We support all stakeholders involved — Sponsor, Hospitals, Clinical Sites and Central Labs — in the development and management of observational clinical studies (with prospective or retrospective data collection on clinical chart or data base) related to medical cannabis.

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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.

THE RIGHT SOLUTION AT THE RIGHT
TIME

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