Process Development
& Optimization
We deliver safe, scalable, and cost-efficient processes that accelerate molecules from pre-clinical to commercial scale.
Route Scouting
& Feasibility
Innovative, and greener synthetic routes validated through gram-scale feasibility studies.
Process
Optimization
Design of Experiments technique to build robust plant-ready processes and control impurities.
Crystallization, Solid-State &
Particle Engineering
Salt/polymorph evaluation with Particle Size Distribution & Morphology control to ensure desired physical parameters.
CMC
Support
Comprehensive Documentation for smooth technology transfer and to support regulatory filings.
Analytical Development
We provide comprehensive analytical solutions that ensure quality, compliance, and reliability across every stage of development.
Method Development &
Validation
Tailored analytical methods built to meet global regulatory standards.
Impurity Profiling &
Characterization
Sensitive detection and identification of impurities and degradants.
In-process, Release &
Stability Support
Seamless support for IPC, release, and stability testing to support data integrity and quality assurance.
Data integrity & compliance-ready Documentation
Compliant and traceable documentation packages to support tech transfer and regulatory readiness.
Process Safety
& Engineering
We integrate safety and engineering excellence into every stage of the process to ensure robust, safe, and reliable scale-ups.
Calorimetric Studies
& Hazard Assessment
Identifying thermal risks and designing safe operating conditions using DSC, ARC etc
Scale-Up
Risk Mitigation
Expertise in handling high-exothermic, cryogenic, and high-pressure reactions.
Process
Engineering Support
Evaluation of process robustness, reproducibility, and sensitivity to critical process parameters
Dedicate Process Safety & Engineering Lab
Miniature equipment to study and mimic plant conditions and perform safety studies for safe scale-up.
Manufacturing
With pilot-scale manufacturing and large-scale manufacturing at the same site, we ensure scale-up activities are seamless
Multi-Purpose cGMP
Manufacturing Infrastructure
Flexible reactor trains and downstream capabilities to support pilot-scale and commercial production of APIs and intermediates, including validation batches.
Dedicated cleanrooms for drug substance
Segregated suites with different MOCs and varying reactor sizes, and 100,000 class cleanrooms, enabling drug substance manufacturing.
High-Complexity Reaction Capability
Safe execution of hydrogenation, high-temperature, and low-temperature chemistries supported by advanced automation.
Reliable GMP
Quality Systems
Robust GMP systems, audit-ready documentation, and disciplined batch execution aligned with global regulatory expectations.
Partner with NewAtom
Let’s explore how we can support your molecule’s journey.
Schedule a meeting with our leadership using the above link, or write to us on bd@newatomlabs.com
