SERVICES
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.
Legals
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
Compliance
Quality Checks
- 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
Dispatch
Product Compliance for Distribution
- 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
- 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
- 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
OTHER SERVICES
How we help producers, breeders & researchers
Product Import
Regulatory and technical services for product importers and sponsors
Planning & Design
Draw on specialist expertise for forward-thinking & commercially sustainable strategies
Operational Support
Accelerate production, improve quality, expand your product portfolio & reduce COGs
Molecular Tests
Provide accurate identification in less than half the time and avoid 90% of cultivation input costs