Medicinal Cannabis Consultants | Global Experts in the Pharmaceutical Cannabis Industry and GMP Sectors
As leading Medicinal Cannabis Consultants, our pharmaceutical industry consultants and engineers have helped companies across the globe learn about the highly-regulated industry of producing medicinal-grade products for domestic use and/or exportation to global markets. Our top medicinal cannabis consultants have expertise in a wide range of medicinal cannabis cultivation business operations. We can advise companies on site selection considerations, facility architecture and clean room designs, as well as risk management procedures, quality management systems (QMS/PQS) compliant with PIC/S and EU GMP, SOPs / work instructions and more.
Our pharmaceutical-cannabis consultancy expertise spans facility architecture and cultivation engineering (climate controls including humidity, heating and cooling; watering and optimal DLI/lighting considerations), as well as laboratory and process designs, data integrity monitoring, and safety and security systems surrounding production, testing, storage, waste management, transportation/distribution and more.
PharmOut’s focus includes a full range of services, helping you design your business facilities and processes to attain maximum yield as well as sustain your GMP compliance and product quality assurance/risk management systems (CGMP / PIC/S) to international regulatory standards (e.g. TGA GMP and FDA GMP requirements and EMA cGMP/EU GMP) for medicinal cannabis production.
Contact us for best practices for designs, processing facilities and workflows for regulatory compliance, current GMP and GDP compliance auditing assistance, and continuous improvement initiatives, including expansions, relocations and supply chains/batch traceability procedures.
From helping you implement your business concepts in terms of regulatory compliance, through to engineering your solutions for cleanroom processing, medicinal extractions and employee GMP training, safety and security, PharmOut is increasingly recognised as the best-practice international medicinal cannabis industry consultancy firm for high-quality pharmaceutical production operations that are compliant with GMP (EU GMP) and PIC/S requirements including the PIC/S Annex’s impacting medicinal cannabis.
Medicinal Cannabis – Regulatory Consultancy for GMP, quality and safety in your facility designs, processes, automation and cleanroom engineering.
Who can help you start your medicinal cannabis business?
PharmOut’s medicinal cannabis consultants can assist you with licensing applications, medicinal marijuana processing and regulatory requirements for GMP / EU GMP (PIC/S).
Our pharmaceutical facility design architects, cleanroom validation, testing and processing engineers are experts in assisting cultivators and medicinal cannabis manufacturers with environmentally-minded designs for efficiency and GMP compliance. Contact PharmOut with your enquiry.
PharmOut’s consultants for pharmaceutical-grade medicinal cannabis cultivation and exportation, and other pharmaceutical and medical device manufacturing sectors, can help you achieve design efficiencies, regulatory compliance processes (SOPs) and mandatory employee and contractor training. These quality management strategies help ensure your quality-tested pharmaceutical products are suitable for the markets you aim to serve (meeting TGA and FDA requirements, ISO9001-2015 standards and other industry-specific regulatory standards).
Our medicinal cannabis consultants work across the globe, with a variety of medicinal cannabis cultivators and producers. Our head office are located in Australia (Melbourne, Victoria) but we have affiliated offices at many major locations including Sydney/Australia, Hong Kong/Asia, New Zealand, the UK, South Africa, the United States (USA) and more.
Cannabis Consulting and Regulatory Compliance expertise including GMP Training, Validation, Architectural and Engineering Services
We’ve helped many of the Australian Medicinal Cannabis Companies seeking facility guidance and ODC licensing and production permits. We have assisted start-ups as well as facilitated international pharmaceutical business expansions, through providing GMP (PIC/S) compliance consultation including in areas of data integrity, seed-to-product batch tracing, cleanroom validation processes, architectural and engineering designs, and employee training services.
- Many companies have already invested, or continue to invest, in businesses working in the cultivation, production, and manufacture of medicinal cannabis products in Australia and elsewhere across the globe.
- For example, places like Israel, Canada and the United States (USA), have attracted extensive industry funding; Australian Medicinal Cannabis opportunities are no different.
With international expertise in regulatory compliance for pharmaceutical manufacturing industries, PharmOut’s Medicinal Cannabis Consultants have been instrumental in assisting more than three-quarters of all successful Australian Office of Drug Control (ODC) cultivation and production license applications; and, to our knowledge, all facilities obtaining Australian Therapeutic Goods Administration (TGA) Good Manufacturing Principles (GMP) manufacturing licenses that are dedicated to the exclusive manufacture of Medicinal Cannabis products.
The Export Market in Australia
- In January 2018, the federal government announced its intent to allow exports of Australian Medicinal Cannabis in the future.
- However, there is currently no framework to support this at this stage in time.
- Regulations are yet to change – especially in relation to the Narcotic Drugs Regulation 2016.
Since 2016, we have been training our best-practice Medicinal Cannabis Consultants including our compliance specialists, architects, engineers and scientists, to become the world-leading Medicinal Cannabis Consultants, helping operators understand and implement cost-effective cultivation technologies and production methodologies to achieve optimal layouts for the head and grow houses. We do our best to help drive down your costs in terms of manufacturing and production. To be considered as one of the world’s leading Medicinal Cannabis Consultants, PharmOut has recruited a number of international cultivation experts into our team.
Site Selection Criteria
The key starting point for investing in and Medicinal Cannabis Facility is the site selection and the process one must follow and a checklist of common mistakes.
We feel that it is critical to match the choice of growing technology Australian weather and cultivation conditions as well as specific Australian Office of Drug Control (ODC) and Therapeutic Goods Administration (TGA) Good Manufacturing Principles (GMP) regulations.
- Site selection for a Medicinal Cannabis facility must still follow traditional site selection principles, such as obtaining planning approvals, traffic management planning and many other building and council regulatory approvals.
- Once these have been checked out, only then can the Office of Drug Control (ODC) licensing application process begin, by completing the appropriate documentation for all aspects of your Australian Medicinal Cannabis ODC License or TGA Manufacturing License.
PharmOut Medicinal Cannabis Consultants have a 100% track record of successfully guiding applicants through the ODC process and have rescued a number of applications, too.
We have not yet failed to guide a company through the ODC and TGA process, and our medicinal cannabis consultants are well placed to help you.
Medicinal Cannabis Manufacturing | History of Licencing
From October 2016, the Australian Office of Drug Control (ODC) began processing license applications for the cultivation, production and manufacturing of medicinal cannabis.
Australia has a well established pharmaceutical-opioid industry, and the regulators are rightfully careful to control access to cannabis so that it is utilised solely for medical purposes.
Obtaining an ODC Cultivation Licence for Medicinal Cannabis in Australia
The main focus of the Australian ODC licence application is an assessment of the control over the crop, as well as people. Our Medicinal Cannabis Consultants will ensure that you facility design is adequate to not place vulnerable communities are at risk and prevent unauthorised access the plants.
Applying for Licences to Manufacture Medicinal Cannabis – API
Two manufacturing licences will be required for the manufacture of Medicinal Cannabis in its Active Pharmaceutical Ingredient form.
Applying for Licenses to Manufacture Medicinal Cannabis – FDF
Two manufacturing licences will be required for the manufacture of Medicinal Cannabis in its Final Dosage Form.
PharmOut offers Architectural, Engineering and compliance project management services to help you get a project up and running as well as compliant with the ODC and TGA regulations.
Facility Design & Planning
Our process engineers and growers, work with our facility architects and HVAC engineers who have extensive experience in designing a wide variety of pharmaceutical, medical device, medicinal cannabis and complementary medicine cultivation, manufacturing and distribution facilities.
Facility Design Reviews
If you already have a medicinal cannabis facility design, we can provide an independent design review, to ensure ODC, TGA and GMP compliance to make sure that all the important details are covered and nothing has been missed.
TGA Regulatory Affairs Consultants
If you’re looking to supply your products to the Australian market but are unsure on the surrounding regulations, we can support you every step of the way.
Quality Management System
PharmOut offers a range of services and products aimed at delivering QMS compliance for medical cannabis cultivators and manufacturers.
Medicinal Cannabis – GMP Training
PharmOut offers a wide range of Validation, GLP, GDP and GMP training courses online, onsite, as well as in a city near you. We also offer a comprehensive Medicinal Cannabis eLearning Training Series aimed at all staff working in Medicinal Cannabis cultivation and production and manufacturing facilities.
If you have any questions you would like to ask, please contact us at one of the PharmOut offices, contact details are here.
If you want to read more about medicinal cannabis, why not check out our Top 10 medicinal cannabis blogs (world’s top 10 blogs about the medicinal cannabis industry)?
If you want to see a case study or some of our medicinal cannabis facility work.
*PharmOut’s architectural, engineering, compliance and process solutions are intended to be used for medicinal cannabis only and where such use, is permitted under state/country law and regulations.