Formulation Development & Manufacturing
We translate your molecule into a robust, scalable dosage form:
- Pre-formulation – Salt-screen & polymorph screening, solubility & stability mapping, forced-degradation studies
- Prototype development – Immediate-release tablets, capsules, oral liquids, lyophilized powders, sterile injectables, topical gels/creams
- Optimization – Design-of-experiments (DoE) to balance dissolution, stability, manufacturability and cost
- Clinical-trial material – Phase I–III GMP batches with packaging (blister, bottle, vial, PFS) and QP release where required
- Tech-transfer & scale-up – Process parameters, master batch records, cleaning validation and operator training for your commercial site
All work is conducted under strict change-control and is supported by regulatory writers who prepare IND/IMPD/CTD sections 3.2.P.