Drug Product Development and Clinical Supplies
We offer a full range of drug product development and clinical supply services, including preformulation studies covering characterization/solid state chemistry, compatibility studies through to the creation of both active and placebo supplies.
Our highly developed formulation services cover solid and liquid dosage, including ophthalmic applications, parenterals and specialized dosage forms.
We use our unique scientific experiece to improve the development of challenging compounds, applying this rigorous attention to detail throughout scale-up, validation and the entire analytical support services, ensuring the highest levels of quality assurance and controls from clinical batch production through to trials.
Our world class project managers ensure your product is handed seamlessly from one group to another. This covers the demanding aspects of clinical packaging and labeling for both commercial and niche products.
At Aptuit Laurus, we have the people and the science to deliver an exceptional service across the widest range of disciplines including:
Pre-formulation studies
- Characterization of drug substance including: polymorph screening; forced degradation; pH solubility; solubility determination; crystalline vs amorphous structure
- Examination of physical properties including: particle size analysis; powder flow analysis; density determination; microscopy
- Excipient compatibility studies
Dosage form development
- Development of solid dosage forms such as tablet capsules, liquids, parenterals and specialized dosage forms such as transdermal patches, gels/hydrogels
- Combination drug products’ development including bi-layered, tri-layered, tab-in-tab et al
- Process capabilities such as granulation (including high shear and fluid bed), compression, coating
- Documentation of information leading to submission of IND
- cGMP lyophilization capability
Preclinical and clinical scale supplies of drug product
- PK/PD and clinical supplies for solid oral dosage forms
Clinical packaging and labeling
- Primary, secondary and tertiary packaging
- Label design, printing, and application
- Process development, scale-up and transfer
- Process optimization; process qualification; process validation
- Pivotal batch production and technology transfer
Analytical development
- Method development and validation (assay, related substance, dissolution etc)
- Ram material testing and release
- Accelerated and full ICH stability studies
Click here to view our Facilties and Equipment