PRESS RELEASE Hunt Valley, MD (October 7, 2024)

Pharmaceutical International, Inc. (Pii), a trusted provider of pharmaceutical development and manufacturing services, today announced the launch of its pioneering Accelevate™ Early Development Platform. This cutting-edge platform 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.

With the global market for early-phase development services valued at approximately $15 billion, Accelevate™ is uniquely positioned to meet the growing demand for accelerated drug development solutions. By addressing the challenges faced by small to mid-sized pharmaceutical companies, Accelevate™ offers a clear competitive advantage, enabling companies to reduce time-to-market while maintaining the highest standards of quality and compliance.

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.

Travis Webb, Chief Scientific Officer of Pii, emphasized the importance of this platform in the current pharmaceutical landscape. “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.”

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.

Pii’s commitment to innovation and excellence comes to life with the Accelevate™ platform, setting a new standard for speed and efficiency in early-stage pharmaceutical development. By delivering a seamless and accelerated path to IND submission, Pii continues to solidify its role as a dedicated ally, enabling pharmaceutical companies to bring new therapies to market faster and with greater confidence.

Pharmaceutics International Inc. (Pii) is a leading Contract Development and Manufacturing Organization (CDMO) that provides comprehensive solutions for aseptic and oral dosage forms. Founded in 1994 by Dr. Syed Abidi, a pioneering formulation scientist, Pii has over 30 years of experience handling complex formulations, potent compounds, and controlled substances. Based in Hunt Valley, MD, Pii’s capabilities include lyophilization, high potency isolation, and robotic filling. Our expert teams ensure the highest quality and safety standards, supporting small to medium-volume projects with scalable solutions and unmatched flexibility. Committed to client-centric drug development, Pii's mission is to enhance quality of life through innovative and high-quality pharmaceuticals. Discover more about our services and how we can support your projects at www.pharm-int.com.