Pharmaceutics International Inc. (Pii), a provider of pharmaceutical development and manufacturing services, has launched its Accelevate Early Development Platform, which is designed to accelerate the preparation of Investigational New Drug (IND) submissions, offering small to mid-sized pharmaceutical companies the ability to reach IND readiness in 100 days for aseptic products.
 
The Accelevate platform addresses a critical need in the pharmaceutical industry, where the pressure to reduce time-to-market has become increasingly pronounced, particularly for smaller companies that lack the internal resources to navigate the complexities of early-stage development. Accelevate offers an innovative approach, integrating Pii’s advanced technology, regulatory expertise, and project management capabilities to deliver a seamless, efficient path from molecule identification to IND submission.
 
Accelevate leverages advanced in silico modeling and machine learning to streamline the development process, ensuring rapid and accurate data generation while maintaining full adherence to FDA, EMA, and ICH guidelines. This sophisticated platform offers comprehensive support, including pre-clinical studies, toxicology, pharmacokinetics, and safety assessments, alongside expert regulatory consultation and the preparation of essential documents for IND submissions. Throughout the process, clients benefit from Pii’s dedicated project management team, which coordinates efforts across functions to ensure the achievement of critical development milestones within the ambitious 100-day timeframe.
 
Travis Webb, Chief Scientific Officer of Pii, remarks: “Accelevate represents a significant advancement for smaller pharmaceutical companies, enabling them to move through the early development process with unprecedented speed. We are empowering these companies to remain competitive in a fast-paced market by reducing the timeline for IND submission without compromising on regulatory compliance.”