Manufacturing
From Concept to Product
“Existing players”
Although in existence for several decades, the Cannabis industry is changing. More and more scientific facts, clinical research, studies and impressive statistic-based information is being published regularly,. Besides the fact that more and more countries are legalizing cannabis, many countries all over the world are enabling more and more patients to use cannabis products including the non-psychoactive ones, such as CBD.
“New players”
We hear daily about the great developments and breakthroughs in the global cannabis industry. The world is becoming “greener” every day and you do not want to miss your entry point to this amazing industry. If you have gained experience and skills from other industries you may leverage this within the world of cannabis.
Quality & Regulation
Current regulatory status and requirements review (local&export)
Potential buildings checking & recommendations
Manufacturing facility construction process inspection
GMP, GDP, ISO and QMS systems basis establishment
Facility and infrastructure systems testing and qualifications
Quality and Operational Management System establishment (GMP, GDP, ISO)
Validation protocols writing
GMP, GDP and Quality Employees training
Manufacturing instructions writing
Validation execution
Employees hiring process and training
Regulatory Mock Audits
Phase I products batches manufacturing and parameters optimizations
Phase I products batches physical, analytical, chemical and microbial testing
Manufacturing processes improvements and manufacturing instructions updates
Manufacturing processes validation
Final product release specifications, label and leaflet definition and design
Final product stability study and shelf life determination
Mock Audit towards external regulatory audit
Audit gaps closing, employees training
External regulatory audit escort
QC laboratory design, equipment, procedures and training*
Technology & Engineering
Project overall Risk Assessment
Products definitions (phase I, phase II, development)
Manufacturing facility conceptual design
Project Basis of Design document writing and approval
Facility conceptual design regulatory pre-approval
Manufacturing technologies comparison and choosing
Manufacturing facility detailed design
Constructors bidding and negotiation process escort
Constructors agreement writing
Full service, technical and process support
Pharma-grade products development
Clinical trials
APIs development
Business & Efficiency
Business goals set up
Project budget, business plan and time lines
Process and laboratory machinery and system purchasing
ERP, control and monitoring system purchasing
Final product package design and branding
Phase I products marketing
Phase II products development
Manufacturing processes cost reduction and yield improvements
Our Stats
GxP – New Standards For Cannabis Products Quality Assurance
GxP stands for ‘Good Practices.’ The "x" can be replaced with Agriculture, Auditing, Documentation, Manufacturing, Clinical, Distribution, Security, Laboratory, Storage, Distribution, Review and others. Good practices are the recommended working [...]
Cannabinoids Crystallization – doing it right!
What is the Crystallization of Cannabinoids? Crystallization is a process when molecules arranged into a well-defined, rigid crystal lattice to minimize their energetic state due to the fact that a [...]
Project Risk Management in the Cannabis Industry
Basics in Risk Management A project, no matter in which industry, is a set of interconnected tasks intended to achieve a certain goal, with a particular set of resources, [...]
Let’s Change the Game
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