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.

Conceptual, basic and detail design

Trimming, drying and packaging departments
Extraction and post processing departments
CBD isolate and full spectrum plants
Value Stream Mapping

Construction management, supervision and commissioning

HVAC System and Utilities
Energy management
Construction Supervision
Overall Equipment Efficiency (OEE) optimization programs
Site Master Plan
Procurement Support and cost estimation
Risk Assessment and Validation service (FAT, SAT, IQ, OQ, PQ)

Technology transfer

Professionals who provide support and train your staff
Implementation of new tech components and processes in downstream workflow
We support you on the right choice of equipment and its provider

Revamping

Revamping solutions for existing departments and facilities in compliance with GACP and GMP regulations
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.

Compliance with regulatory bodies advisory

Quality system documentation hierarchy design
Workflow definition & Standard template alignment
Draft procedures with reference applicable standards (GACP, GLP, GCP, GMP, PIC/s, ICH Guidelines etc.)
Inspection Readiness and on site support

Achieve total quality control over production and processes

Process Validation
Risk Analysis Management
Analytical Method Development and Validation
Cleaning Validation

Risk-based auditing and monitoring

GxP and ISO certified quality system application
A Global network of local auditors ready to execute audits worldwide operating from PQE subsidiaries and offices
Remote audits whenever on-site audits are not allowed due to restrictions

GCP compliance activities

QMS implementation
QA outsourcing support
GCP Auditing
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.

Worldwide regulatory strategic plan

Reach any country, assuring dedicated coverage leveraging on PQE group global office network
Up-to-date local and global regulatory status and requirements review

Support for product registration and authorization

Preparation of necessary documentation for regulatory bodies according to current requirements
Dossier compilation and publishing

Engagement and follow-up with regulatory bodies

Manage products’ approval and registration
Improvement and standardization of regulatory processes
Preparation of product registration documents
Final product release specifications

CTD life-cycle management

Assemble and collect all the Administrative, Technical, Quality, Safety information in a common format (CTD)
Support for the CTD submission process according to the current regulations and requirements of the country
Submit correct classification and grouping of variation in order to reduce time and effort
Implementing any required changes in order to keep the CTD up to date
Support 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.

Cannabis biochemistry studies

Specification of precise plant attributes needed
Mapping of alternative hybrids and genetics aspects meeting your specific project goals
Crossbreeding studies and strategic planning
Isolation, identification and biosynthesis of cannabinoids

Complete cultivation cycle management

GACP compliance
Cultivation strategy
Seeds and plants handling
Cultivation & environmental conditions
Plant protection
Harvest conditions & techniques
Drying process
Packaging & storage
Cultivation and post-harvest costs reduction/yield improvements

R&D support

Scientific and clinical research support
Ongoing research assessment & troubleshooting
Alternative hybrids R&D (Third-party Lab)
Providing the structure and the experts to meet your demands
Third-party pharma study with Lab trial support
High quality product development support
Product development

Process validation

Choosing the right extraction method that suits the scope of customer’s project
Extraction facility planning and safety requirements
Extraction validation
Process optimization

Patentability advice and IP protection

Coming soon

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.

Medical writing

Investigator Brochure
Study protocol
Informed Consent
Study report
IMPD

Clinical operation

Project Management
TMF management
Site Monitoring
Investigational product management

Data management and statistics

Set up and validation of the eCFR
Data management Plan
Data cleaning & Database lock
Statistical Analysis Plan and Report
Statistical analysis set up, validation and running

Regulatory and safety

Collection and submission of Clinical Trial Application initial and life cycle management
Clinical Observational studies submission to Competent Authorities and Ethical Committee
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.

E-learning platform

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

Webinars & workshops

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

On-site custom-made courses

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

Compliance training

Drug Prescription
Medical Cannabis Product Information
Clinical Data
Drug Administration
Therapeutic Potential Strategies

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.

Services

Engineering

GxP Quality Compliance

Regulatory Affairs

Scientific Advisory

Clinical Studies

GQC Academy

THE RIGHT SOLUTION AT THE RIGHT
TIME

Glocal Quality Cannabis

GQC

Industry

Useful Links

Services

Engineering

GxP Quality Compliance

Regulatory Affairs

Scientific Advisory

Clinical Studies

GQC Academy

THE RIGHT SOLUTION AT THE RIGHT TIME

Glocal Quality Cannabis

GQC

Industry

Useful Links

THE RIGHT SOLUTION AT THE RIGHT
TIME