Phase-appropriate R&D for customer molecules in the early phase of drug development.
Comprehensive safety research, testing, and evaluation services aligned with global regulatory standards.
Experienced team and infrastructure to support rapid systematic technology transfer and production.
Seamless transition from laboratory-scale development to scalable production, ensuring efficient and compliant manufacturing processes.
End-to-End CMC support, ensuring seamless IND application.
Reliable and reproducible analytical data to support speedy filing for regulatory approval.
Ensures compliant, consistent small molecule production with Process Validation & Qualification from development to manufacturing
Aragen ensures regulatory compliance and QA for small molecule drug development from research to commercialization.
Dedicated HPAPI facility for handling potent compounds.
Aragen optimizes drug development with Particle Science and Engineering services from research to final optimization
Optimizes small molecule manufacturing with Process Development, ensuring efficiency, quality, and cost-effectiveness
Comprehensive safety research, testing, and evaluation services aligned with global regulatory standards.
We ensures scalable, robust, and compliant late-phase technology transfer for seamless large-scale production
Reliable and reproducible analytical data to support speedy filing for regulatory approval.
Aragen ensures late-phase process validation for scalable, regulatory compliant drug manufacturing and commercialization
Aragen ensures regulatory readiness for late-phase trials, NDA/BLA submission, and successful compliance review
We excel in developing and manufacturing high-potency APIs and compounds, from immunosuppressants to ultra-potent cytotoxic substances and ADC toxins, ensuring reliable solutions for diverse pharmaceutical needs.
Aragen optimizes drug development with Particle Science and Engineering services from research to final optimization
State-of-the-art facilities enable scientists and engineers in adopting data-oriented development approach to ensure flawless scale-up.
Aragen ensures safe, compliant, and scalable commercial-phase small molecule production with rigorous safety assessments
Aragen ensures high-quality, cost effective, and compliant large-scale production for commercialized drug products
Reliable and reproducible analytical data to support speedy filing for regulatory approval.
Aragen ensures GMP-validated commercial processes with continuous monitoring for consistent, high-quality drug substance production
Aragen supports commercial production transition with ongoing GMP compliance, regulatory filings, and post-market surveillance
Dedicated HPAPI facility for handling potent compounds
Our value proposition lies in our experienced and talented team, adept at managing cross-functional transitions effectively. This expertise facilitates efficient and swift project progression from pre-IND to NDA and beyond through strong cross-functional linkages. Our development philosophy emphasizes phase-appropriate development, prioritizing speed in early phases, and early evaluation of regulatory, safety, and engineering aspects. We are committed to creating safe, robust, and scalable processes with a constant focus on sustainable and green opportunities.
Seamless integration across multiple functions, including Environmental Health and Safety (EHS), project management, quality control, quality assurance, regulatory affairs, and supply chain management, is at the core of our operational excellence. Our commitment is to meet and exceed customer expectations on quality, quantity, and on-time supply of drug substances.
