01 / Development to launch (D2L)
CMC & Product Development
One team owns the molecule from bench to commercial launch. Every design decision starts with the clinical need (QTPP) and the patient, and carries the P&L and the regulatory pathway in view from the first batch.
Oral solids, modified and controlled release
Oral disintegrating tablets (ODTs), buccal and sub-lingual tablets
Liquid orals: solutions and suspensions
Simple to complex injectables and sterile products
Nasal, ophthalmic and inhalation (DPI and nasal delivery)
Pediatric dosage forms: liquids, taste-masked ODTs, mini-tablets
Specialised technical capability
HPAPI development and setting up high-potent facilities
Bioavailability enhancement for poorly soluble molecules
API selection, preformulation and polymorph screening
QbD-driven formulation development
Stability strategy and lifecycle management
Process development, scale-up and tech-transfer
Quality by Design (QbD) based product development
Process validation and commercial launch
CMC documentation for regulatory submissions
Manufacturing and supply-chain risk assessments
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