Preparing a herbal product for marketing authorisation
The quality stages, documents, and production partners to prepare from the very start of downstreaming so that registration does not stall.
Many herbal products stall at the registration stage because quality documentation wasn't prepared from the start. Raw-material standardization, consistent active-compound levels, and process records must be built alongside formulation development.
The next step is finding a certified production partner. Moving the process from lab scale to a certified facility requires adjustments to the formula, packaging, and work procedures, all of which must be re-documented.
This experience now underpins DHK-STP's mentoring approach: the regulatory roadmap is set at the earliest gate, with document requirements coordinated with the Directorate of Innovation and Intellectual Property as the upstream stage.