Accelerate Your Path to IND Readiness with Accelevate™
Introducing Accelevate™—Pii’s groundbreaking Early Development Platform Solution, designed to help pharmaceutical innovators achieve IND readiness in under 100 days. Tailored specifically for small to mid-sized pharmaceutical companies, Accelevate™ streamlines every step from pre-clinical formulation development to early-phase clinical trials, focusing on parenteral drug products with small molecule APIs.
The Challenge: Speed Meets Complexity
In today’s fast-paced pharmaceutical landscape, small to mid-sized companies face mounting pressure to bring new therapies to market faster. However, traditional drug development can take up to a year to reach IND submission, with complex data collection, study coordination, and regulatory compliance hurdles. Accelevate™ bridges this gap, enabling companies to move swiftly while ensuring quality and compliance every step of the way.
Why Choose Accelevate™?
Accelevate™ offers a unique blend of speed, efficiency, and expertise, delivering fast, early development solutions for aseptic drug products while meeting regulatory standards, all without compromising on quality.
Core Service Components:
- Accelerated Timelines: Rapid formulation and analytical development, aimed at meeting aggressive first-in-human and Phase 1 clinical deadlines.
- Comprehensive Data Generation: Pre-clinical studies covering toxicology, pharmacokinetics (PK), safety assessments, and more.
- Regulatory Expertise: Pii’s team provides expert consultation and preparation of detailed data tables and diagrams for IND submissions, ensuring a smooth regulatory process.
- Dedicated Project Management: A committed team ensures seamless coordination, keeping your project on track to meet the 100-day IND goal.
Cutting-Edge Technology at Your Fingertips
Accelevate™ leverages Pii’s advanced technology and digital infrastructure to speed up data collection and analysis, reducing lab time and optimizing outcomes.
- In Silico Modeling: Gain instant insights into the molecular properties, stability, and metabolism of your drug substance with advanced ADMET and Physchem modeling.
- 3D Solubility Mapping: Rapidly screen solvents with 3D mapping, optimizing solubility in fewer bench trials.
- Machine Learning & Databases: Trainable databases and multivariate regression modeling minimize lab time while creating robust formulations.
Regulatory Compliance You Can Trust
Accelevate™ adheres to FDA, EMA, and ICH guidelines, ensuring that all studies are conducted under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. With global regulatory expertise, Pii ensures your data is submission-ready for authorities worldwide.
Ready to accelerate your IND filing? Contact us today to learn how Accelevate™ can shorten your time to market and help you stay competitive in an increasingly fast-paced industry.
Check Out More of Our Resources
Managing the Challenges of
Small Batch Formulations
How to Clear 5 Early-Stage Development Hurdles
