Aptuit

Aptuit is a company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators. We apply a completely different mindset to the drug development industry, offering a modern business strategy aimed at revolutionizing the entire process, from drug discovery through commercialization.

Aptuit is the first provider to combine industry-leading drug development consulting expertise, state-of-the-art GMP/GLP facilities, innovative technologies designed specifically to expedite the development process, complete project management capabilities, and comprehensive regulatory compliance services, all in one package. Customers can select distinctive parts of the mix, or an end-to-end solution.

To assist customers, Aptuit offers a truly modular approach to drug development that addresses the complexities and inefficiencies that make the current process prolonged and expensive. Aptuit designs therapy or product-specific programs for clients, leveraging their collective expertise and a deep understanding of the drug development process to identify potential hurdles and address them at the onset. In addition, Aptuit offers centralized project management to navigate and manage the process for customers as their molecule or compound advances from inception through clinical development. Finally, Aptuit works to make the entire process truly transparent by establishing the industry's first seamless IT system, which will allow customers to access their data anywhere in the world, in real time.

Currently, Aptuit provides a comprehensive suite of drug development services and competencies to more than 250 pharmaceutical and biotechnology companies worldwide.

Services encompass the following activities, which can be provided in a seamless continuum or in modular form:

• Regulatory and Strategic Consulting: program design, regulatory submission preparation, quality and compliance auditing, validation documentation
• Informatics: development, implementation, and maintenance of enterprise-class, mission-critical information systems for the drug development market
• Discovery Support: high throughput screening, informatics, libraries, lead optimization
• Preclinical Technologies: pharmacology, toxicology, bioanalysis, ADME
• Clinical Services: clinical supplies manufacturing, packaging and distribution in support of Phase I through Phase IV clinical studies, support and consulting services to allow rapid implementation of proof-of-concept studies
• Drug Substance Development: API route development, process demonstration, scale up and supply

• Drug Product Development: formulation, analytical method development and stability testing, preformulation, novel drug delivery