Services

Innovative offerings across the drug development lifecycle

NewAtom Labs offers innovative and tailored research and manufacturing services for intermediates, APIs, and specialty chemicals. We collaborate closely with clients at every stage of their development process, from conceptualization to commercialization. Our commitment to excellence and customer-centric approach ensures that we accelerate your drug development initiatives and deliver value on all our engagements. From initial R&D to commercialization, we have flexible offerings to partner with you across the pharmaceutical development value chain.

Our capabilities include route scouting, process development and optimisation, process safety evaluation, analytical method development and validation, impurity isolation and identification, spike and purge studies, CMC documentation, stability studies and manufacturing of drug substances for toxicity assessment, clinical studies and commercialisation.

Process Development and Optimization

With a team of 60 R&D scientists and engineers boasting rich CDMO experience, our multidisciplinary group specializes in phase-appropriate process research and development during drug development.

Analytical Development and Validation

At NewAtom, we specialize in designing, developing, and validating analytical methods based on the specific phase of drug development.


Process Safety and Engineering

We prioritize the safety and environmental impact of our processes and operations based on Process Hazard Analysis and HAZOP studies.

Manufacturing

We pride ourselves on our extensive experience in pharmaceutical manufacturing. Whether you’re developing New Chemical Entities (NCEs), APIs, or advanced intermediates, we’re here to support your journey from clinical trials to commercial production from our USFDA audited manufacturing site.
 

Want to partner with us for your drug development initiatives?


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