Facilities & Scale
Vertical integration: in-house equipment manufacturing & maintenance team enabling a closed loop from custom machinery and process validation to contract production.
2,400 m² GMP workshop: ODF-oriented zoning (compounding/casting/converting/packaging/retains) with environmental monitoring and lot traceability; cleanroom/temperature-humidity controls aligned to project needs.
800 m² laboratories: formulation screening, accelerated/long-term stability, sensory, and baseline physico-chemical testing; supports parameter mapping from pilot to commercial lines.
2,000 m² equipment shop: custom casting lines, slitting & die-cut modules, in-line vision & thickness gauging, packaging modules, with mech/controls/software integration, spares, and refurbishment.
Rapid on-site support: on-site within 10 days when required (subject to travel/clearance/safety), covering installation, commissioning, training, and maintenance.
Client value: the same team sits across formulation–process–equipment, reducing ramp-up time and change/control risk.
People & Responsibilities
Cross-functional project team
Project Manager (PM): milestones, risk/change control, weekly reporting, single point of contact.
Formulation & Process Engineers: target mouthfeel/disintegration/dissolution and CU; define design space & control strategy.
QA/QC: document control, batch records, deviations/CAPA, incoming–in-process–release testing, retains.
Equipment & Automation Engineers: casting/drying/tension/registration, in-line thickness & vision, packaging seal/coding integrity.
Validation & Field Service: IQ/OQ/PQ, operator training, after-sales maintenance, spare-parts readiness.
Training & competency
On-boarding (SOP/safety/PPE/data integrity ALCOA+) → annual re-qualification; dual-role backups for critical posts.
“Mentor + shadow” during trials and first commercial runs to suppress ramp-up deviations.
Service Level (SLA)
Business-day response ≤24 h; initial deviation triage ≤48 h.
Emergency trigger: on-site within 10 days (destination-dependent) with remote pre-diagnosis and pre-positioned spares.