GMPLEX™ CDMO
Outsource your manufacturing to us.
For companies seeking an end-to-end manufacturing partner, GMPLEX™ provides integrated CDMO services spanning development, technology transfer, GMP manufacturing, quality assurance, quality control and batch release.
You bring the product. We manage the manufacturing.
What's included
A single accountable partner across the full product lifecycle, from development through to released batches.
Development & formulation
Formulation development, pre-formulation studies and scale-up strategies designed for a smooth path into GMP manufacture.
Technology transfer
Structured transfer of your process into GMPLEX™ modules, with documented protocols, risk assessment and engineering batches.
GMP manufacturing
Clinical, registration, validation and commercial batches manufactured in TGA-aligned, PIC/S-compliant modules.
Quality assurance
Documentation control, deviation and change management, validation lifecycle and audit-ready quality systems.
Quality control testing
Analytical method transfer and validation, in-process and release testing, plus stability programs.
Batch release
Review and release by qualified personnel, with full traceability and regulatory documentation packs.
Best suited to
- Early-stage and emerging pharmaceutical companies
- Clinical and registration batches
- Companies without internal manufacturing capability
- Organisations wanting to avoid investment in their own GMP facility
How engagement works
- 01
Scoping
We review your product, dosage form, volumes and timelines.
- 02
Feasibility & quote
Technical feasibility, materials plan and a costed program.
- 03
Transfer & trial
Process transfer, engineering and trial batches with documented outcomes.
- 04
GMP batches
Clinical, registration or commercial manufacture under full GMP.
- 05
Release & supply
QC testing, batch release and ongoing supply planning.
Ready to outsource your manufacturing?
Start as a GMPLEX™ CDMO customer, then scale into Managed Manufacturing or your own Dedicated GMP Module when you're ready.