Project scoping & feasibility
We review your molecule, target dosage form, target market, and development status to define project scope and timeline.
Contract development and manufacturing managed from Singapore, produced at our GMP manufacturing partner, with full HSA regulatory support.
INNORINI PTE. LTD. (UEN 202015523Z) provides CDMO (Contract Development and Manufacturing Organisation) project management from Singapore through our qualified GMP manufacturing partners. We manage formulation development, analytical method development, stability studies, technology transfer, pilot scale-up, commercial manufacturing, and HSA regulatory submissions. We are a Singapore-regulated CDMO project partner, not a Singapore-based manufacturer.
At a glance
A CDMO provides both product development (formulation, analytical methods, stability) and manufacturing services under one contract. Innorini's model places project management, regulatory strategy, and quality oversight in Singapore, while development and manufacturing are executed by our GMP manufacturing partner network.
This structure gives overseas pharmaceutical companies a single point of contact in Singapore, access to cost-competitive GMP manufacturing capacity through our partners, and the regulatory credibility of a Singapore-registered company managing the HSA registration and import process.
| Service | Available | Where Performed |
|---|---|---|
| Pre-formulation screening | Yes | our partner facilities |
| Formulation development | Yes | our partner facilities |
| Analytical method development | Yes | our partner facilities |
| Stability studies (ICH) | Yes | our partner facilities |
| Pilot scale-up batches | Yes | our partner facilities |
| Process validation | Yes | our partner facilities |
| Technology transfer | Yes | partner site / Client site |
| Commercial GMP manufacturing | Yes | our GMP manufacturing partners |
| Regulatory dossier (CTD) | Yes | Singapore |
| HSA submission & query management | Yes | Singapore |
We review your molecule, target dosage form, target market, and development status to define project scope and timeline.
our GMP partner network conducts pre-formulation, formulation optimisation, and analytical method development under GMP conditions.
Pilot scale-up batches are manufactured and placed on ICH stability studies to support regulatory submission.
The process is transferred to commercial scale and validated with three consecutive validation batches.
We compile the CTD dossier and submit to HSA, managing all queries and requests for additional information.
Upon approval, our GMP partner network handles commercial manufacturing while Innorini manages import, packing, and distribution.