Aligns Pharma Science is a trusted Contract research organisation in india with a fully integrated drug discovery platform operating from our state-of-the-art research facility in Ahmedabad, India. We specialize in discovery chemistry, offering expertise from hit identification to lead optimization, Our in-house capabilities allow us to execute mg to kg scale synthesis programs efficiently and with high precision.
We are particularly known for our expertise in impurity synthesis, including EP impurity and USP impurity standards, as well as reference standard to supporting Active Pharmaceutical Ingredient (API) development, Nitrosamine impurities and regulatory submissions.
Our experienced team of chemists excels in the synthesis of small molecule NCEs with strict quality specifications. We utilize a wide range of synthetic methodologies to prepare multi-step compounds, small arrays, and focused libraries—all tailored to your unique R & D needs.
Each compound delivered is accompanied by complete characterization data, including high-field NMR, mass spectrometry, IR specroscopy and purity analysis by LC-MS, HPLC, or GC. We also specialize in the development of reference standards for pharmaceutical impurities to ensure compliance and analytical accuracy.
With access to global databases like SciFinder and Beilstein, our chemists stay current on the latest research, enabling innovation in route design and impurity identification.
Our Chemistry Expertise Includes:
- Chiral chemistry
- Aliphatic, aromatic, and heterocyclic chemistry
- Carbohydrate chemistry
- Peptide and nucleoside chemistry
- Steroid chemistry
- Natural product and fragment library synthesis
- Metabolite, impurity, and reference standard synthesis
- Microwave-assisted organic synthesis
- Combinatorial chemistry
CDMO Services
Aligns Pharma Science also offers end-to-end CDMO services, enabling seamless transition from medicinal chemistry to early scale-up. Our dedicated PR&D team lays the foundation for rapid development, impurity profiling, and delivery of key project milestones.
We understand that scaling a MedChem route requires a tailored approach. Each process is evaluated independently to ensure safety, efficiency, and regulatory readiness—especially for impurities and advanced intermediates.
Our PR&D Capabilities:
- Route scouting and impurity control strategy
- Process design and optimization
- Scalable synthetic route development
- Synthetic demonstration and batch manufacturing
- Analytical method development for impurities and stability studies
- Salt screening and polymorphism analysis
- Technology transfer to pilot plant
Whether you need EP impurity standards, USP reference standard synthesis, Aligns Pharma Science is equipped to deliver reliable, regulatory-compliant solutions to support your drug development lifecycle.