We offer complete dosage form development solutions for NCE clinical formulation, differentiated generic and over-the-counter product development. Our drug product expertise covers all routes of delivery namely oral, parenteral, ophthalmic, topical and inhalation routes. Drug product development includes ideation, strategy, adaptation of preformulation technology, process development, packaging development, analytical development and validation, stability studies, technology transfer to ensure successful cGMP manufacturing.
We offer complete dosage form development provide formulation solutions to develop appropriate dosage form for Phase I/II/III clinical studies of new chemical entities. Clinical stage formulation development includes adaptation of preformulation technology, thorough process development, dosage form development, drug product analytical development and validation, stability studies, technology transfer to ensure successful cGMP manufacturing and clinical supplies.
Molecules with right drug delivery technology can assure successful outcome from clinical studies and avoid repetition.
We offer complete dosage form development solutions for differentiated generic and over-the-counter product development including ideation, development strategy and proof of concept studies to reach full development decision. Our drug product expertise covers all routes of delivery namely oral, parenteral, ophthalmic, topical and inhalation routes. Drug product development includes thorough process development, packaging development, analytical development and validation, stability studies, technology transfer to ensure successful cGMP manufacturing.
Differentiated products are the novel ways to deliver previously approved molecules to improve their pharmacological, pharmacokinetic properties or patient compliance by developing a new dosage form, alternative route for administration, intermediate strengths, new drug combinations, improving patient compliance by reducing pill burden, taste masking etc.
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