IND Enabling Services

The investigational new drug (IND) application marks a pivotal moment in your drug’s journey. As per the Food and Drug Administration (FDA) guidelines, an IND submission necessitates comprehensive elements, including animal pharmacology studies, toxicology studies, manufacturing details, clinical protocols, and investigator information.

At Aragen, we offer comprehensive CMC (Chemistry, Manufacturing, and Controls) support for your IND application from process chemistry and drug substance manufacturing to formulation development and manufacturing. Throughout this journey, our analytical team conducts rigorous quality analysis to ensure that your program meets its milestones. With collaborative efforts from process chemistry, drug product, and analytical experts working together, we maximize the potential success of your molecule.

Aragen’s IND Enabling Services encompass a comprehensive suite of offerings that play a pivotal role in advancing drug development from early stages to Investigational New Drug (IND) filing. These services are designed to ensure the successful transition of a potential drug candidate from discovery to clinical trials. 

• Process Chemistry: Aragen’s Process Chemistry services focus on optimizing and developing robust synthetic routes to produce drug intermediates and final Active Pharmaceutical Ingredients (APIs). The team employs state-of-the-art technologies to design scalable and efficient processes, minimizing impurities and ensuring the synthesis is economically viable. 
• Drug Substance Development and Manufacturing: Aragen excels in Drug Substance Development and Manufacturing, providing end-to-end solutions from process development to cGMP manufacturing. The emphasis is on producing high-quality drug substances with reproducible processes, meeting regulatory requirements for clinical trials. This involves process scale-up, optimization, and thorough characterization. 
• Pre-formulation and Formulation Development: Pre-formulation and Formulation Development services at Aragen aim to enhance the bioavailability, stability, and overall performance of a drug candidate. This involves selecting suitable excipients, optimizing formulations for various dosage forms, and conducting compatibility studies. The goal is to develop formulations that meet the specific needs of the intended drug delivery system. 
• Drug Product Manufacturing: Aragen’s Drug Product Manufacturing services cover the production of clinical trial materials following cGMP guidelines. This includes dosage forms such as tablets, capsules, and sterile formulations. The focus is on ensuring scalability, reliability, and compliance with regulatory standards. Quality control measures are implemented throughout the manufacturing process to guarantee the consistency and safety of the drug product. 

By integrating these services, Aragen provides a seamless pathway for clients looking to progress their drug candidates through the IND-enabling stages. The multidisciplinary approach and commitment to quality make Aragen a trusted partner in advancing drug development programs.