ALean

Entries by Alanna
insurance-for-medicinal-cannabis-operations1

Medicinal Cannabis Stability

As the medical cannabis industry matures, a question has started popping up more frequently regarding medicinal cannabis stability, namely: “What do I put down for shelf life/expiry for a new medicinal cannabis product?”

In this …

APVMA-GMP-Training-Australian-code-of-GMP-veterinary-chemical-products

S4 CBD for pets and livestock

Given the TGA’s strict supply pathways it would be easy to assume that medicinal cannabis is reserved solely for humans, however, this is not the case. In fact, veterinarians are also able to use …

Young-doctor-offering-pill

Compliant Medicinal Cannabis Advertising

As many in the pharmaceutical industry know, the TGA has strict rules on advertising therapeutic goods. These rules are outlined via the Therapeutics Goods Advertising Code as well as guidance provided in Australian Regulatory …

can-you-insure-cannabis-crops-insurance

The Future of CBD

Many heralded the TGA’s proposal to downschedule low-dose cannabidiol (CBD) to S3 as groundbreaking, however, as I’ve covered in a previous blog, there are additional complications that need to be addressed. The TGA’s initial …

FDA Metrics tracker

Updated FDA 483 citations analytics tool

As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a supply and just in time, QikSolve have …

TGA Regulatory Affairs Consultants

PIC/S GMPs vs WHO GMPs – what’s the difference?

As many are aware, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) develops and provides standards and guidelines for the harmonisation of Good Manufacturing Practice(GMP) in the global pharmaceutical industry.

Those who fall under the umbrella of …