Regulations & Compliance


Regulations & Compliance

Assistance navigating cross-border regulations, and ensuring you always meet the various types of compliance criteria.

Production and global trade of Cannabis requires traversing a complex legal landscape and highly-regulated manufacturing standards across multiple jurisdictions. Mistakes can cause lengthy delays and impasses. Profitability depends on compliant regulatory management.



Licencing & Regulatory Affairs

Efficient and accurate applications and response to regulator requests saves time and money.

  • Medicinal Cannabis licencing, permits, inspections & variations
  • Low-THC and dual-use crop regulatory management
  • Import-export / medicines-poisons licences & permits
  • Technical responses to regulator request for information


Quality Checks

100-point on-site audit to validate your approach to quality against TGA and EU-GACP requirements.
  • Staff management & training
  • Facility design, layout and environment control
  • Equipment specifications & operations
  • Cultivation & post-harvest practices
  • Input materials for cultivation
  • Batching & quality validation
  • Documentation & SOPs review


Product Compliance for Distribution

Quality systems and SOPs to standardise production processes and document compliant supply.
  • Meet Cannabis standards: TGA, GACP, EU-export
  • Regulatory and validation roadmaps for export and local sales
  • Quality management systems covering cultivation & primary processing
  • Detailed SOPs tailored to your production processes
  • Technical staff training

Reduce risks by ensuring you meet the licencing and compliance criteria for production, sales and distribution.

Compliance Process


Mandated regulatory & quality requirements

  • Australian and European market regulations & product specifications
  • TGA, EU-Pharmacopeia, EU-GACP,DAB ( Germany)

Comprehensive audit against product requirements

  • Review of quality documentation systems
  • On-site facility and operational audit
  • Gap & risk analysis against target products & market requirements

Quality documentation and operational systems

  • Electronic document management system
  • Tailored SOPs, WIs, forms and technical reports
  • Batch Records and validation dossier development

3rd party evaluation of your compliant production

  • Prepare for validation of supply by potential off-take partners
  • Globally-recognised third-party certification

GACP Compliance

EU Compliance and Audit Support

  • No harmonised legislation in the EU
  • Germany is the fastest growing market
Following monographs standardise identification, purity & content requirements for German market:
  • DAB 2017 Cannabis flos (flower)
  • DAB 2020 Cannabis extract, standardized

General ‘safety’ standards in Eu Pharmacopoeia:

  • Microbiological quality (Ph. Eur. 2.6.12, 2.6.13, 2.6.31)
  • Microbial toxins (Ph. Eur. 2.8.18, Ph. Eur. 2.8.22)
  • Pesticides (Ph. Eur. 2.8.13)
  • Heavy metals (Ph. Eur. 2.4.27)

Triffid BioScience GACP quality system

Our GACP quality system documents compliant cultivation & ensures quality standards are met.
  • Botanical identity of starting materials
  • Cultivation – input materials
  • Cultivation – propagation
  • Cultivation – crop establishment
  • Cultivation – crop management
  • Cultivation – crop remediation
  • Harvest
  • Primary processing
  • Storage & distribution
  • QC, sampling & analytics
  • Waste management
  • Facilities & equipment management
  • Documentation & records management


How we help producers, breeders & researchers

Regulations & Compliance

Product Import

Regulatory and technical services for product importers and sponsors

Planning & Design

Planning & Design

Draw on specialist expertise for forward-thinking & commercially sustainable strategies

Operational Support

Operational Support

Accelerate production, improve quality, expand your product portfolio & reduce COGs

Molecular Breeding

Molecular Tests

Provide accurate identification in less than half the time and avoid 90% of cultivation input costs