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The Challenges of Psilocybin Legal Licensing and Compliance

Ryan Pincura, Director of Regulatory Affairs, Tendrel Group

Psilocybin licensing requirements differ from one jurisdiction to another, therefore the general understanding through experience of controlled substance applications and the typically minimal government regulatory requirements is a must. Licensing requests for more information (RFIs) are inevitable and having the understanding and experience to provide the appropriate response can make or break your organizations’ ability to be issued the licence. It is also imperative that the understanding of the wait times to acquire the finalized components of the licensing is integrated with the available investment capital to allow for the functionality of the business. Plan, design, implementation and the eventual operations of a psilocybin facility can be financially daunting. Proper forethought towards the required expenditures is necessary to keep the company's head above water and to come out of the gates competitive.

During this webinar we will discuss:

  • How to complete an application submission
  • Capital expenditures
  • Security and product distribution
  • Facility design, accreditation and GMP/GPP
  • Analytical analysis
Ryan Pincura
Director of Regulatory Affairs, Tendrel Group