Medicinal Cannabis Consultants

Medicinal Cannabis Consultants
Click this image to read more about PharmOut’s proven track record in medicinal cannabis facility design

Medicinal Cannabis Consultants

As the leading Medicinal Cannabis Consultants, our team has helped most of the Australian Medicinal Cannabis Companies by providing Medicinal Cannabis consulting, compliance, validation, architectural, engineering and training services. Many companies have invested and continue to invest in the cultivation, production, and manufacture of medicinal cannabis products in Australia and elsewhere, i.e. Israel, Canada and the USA, the Australian Medicinal Cannabis opportunities are no different.

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.

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 to the Narcotic Drugs Regulation 2016.

Since 2016, we have been training our Medicinal Cannabis Consultants which includes compliance specialists, architects, engineers and scientists to become the world leading Medicinal Cannabis Consultants on the most cost-effective cultivation technologies and methodologies to achieve optimal layouts for the head and grow houses to ensure we do our best to drive down your cost of manufacture.

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.

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.

Medicinal Cannabis Flowering Stage
PharmOut’s international growers can design your grow house.

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 can 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, we are well placed to help you.

Medicinal Cannabis Manufacturing

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 opioid industry and the regulators are rightfully careful to control the 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.

Project Management

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 complaince 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 1 day intensive Australian Medicinal Cannabis Training Course aimed at all staff working in Medicinal Cannabis cultivation and production and manufacturing facilities.

More Information:

If you have any questions you would like to ask, please contact us here.
If you want to read more about medicinal cannabis, why not check out our blogs?

*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.