Regulatory Intelligence
Certification is a point-in-time event; the regulatory landscape underneath it keeps moving. This advisory line keeps a facility's programme current between formal audits — not just prepared for the last one.
The standards behind the standards, watched continuously.
Ph. Eur. Monographs
European Pharmacopoeia updates that change what "compliant" means for herbal and cannabis-derived materials.
ICH Q9(R1) & Q10
Revised quality risk management (Q9(R1)) and the pharmaceutical quality system guidance (Q10) that CAPA and audit programmes are built against.
EU-GMP Annex 11 (Draft)
The computerized-systems annex currently under revision — directly relevant to any facility running digital compliance systems.
CanG / MedCanG & Thai Reclassifications
Germany's Cannabis Act and Medical Cannabis Act framework, and Thailand's ongoing 2025–2026 reclassification moves — both directly reshaping who can cultivate, process, and export what.
A facility can pass an audit and still drift out of compliance.
Standards move continuously; a facility that passed its last formal audit can still be out of step with the current baseline by the time the next one arrives. This is the line of work that keeps that from happening — especially relevant for DTAM-GACP holders navigating Thailand's active reclassification process.