Development & Manufacturing Excellence

The journey of a drug substance through medicinal chemistry rarely concludes with an ultimate production route. Scaling a drug substance from milligrams to kilograms entails much more. Establishing an efficient process at the project’s outset, avoiding shortcuts, defining clear responsibilities for all stakeholders, and fostering a collaborative mindset across disciplines are pivotal. In the long term, route scouting is a time and cost-saving endeavor, while a dedicated focus on appropriate analytical methods ensures impurity control and enhances drug substance safety.

Transitioning from Research to Development

Integrated drug discovery services encompass a range of offerings designed to bolster and expedite drug development while cutting down the time and expenses required for introducing new drugs. The drug discovery process is intricate and demanding, spanning various phases such as target identification, lead discovery, optimization, preclinical, and clinical development. These comprehensive services excel in identifying potential challenges at an early stage of drug development, thereby contributing to cost savings by mitigating the expenses linked to unsuccessful drug development initiatives.

Development Services

Process Chemistry Services

Our dedicated process chemistry team is committed to aiding you in route scouting and crafting a process tailored to your project's needs. This process guarantees safety, reproducibility, robustness, and superior quality. All our process development endeavors are guided by Quality by Design (QbD) principles, integrating analytical and risk-management methodologies throughout molecule design, development, and manufacturing stages.

Route Exploration and Process Development

The process begins with designing the route, which involves conducting retrosynthetic analysis, practical evaluation for yield enhancement, and ensuring safety through thorough thermodynamic studies. This leads to route investigation, encompassing in-depth exploration of potential routes and method development. The process is developed, optimizing both early and late-stage processes, employing strategically designed experiments (DoE), and troubleshooting reactions.

Tailored Scale-Up Solutions

Navigating the transition from preclinical to commercial-scale manufacturing brings intricate challenges and intricacies. Our custom scale-up service encompasses in-house production ranging from hundreds of grams to kilograms of non-GMP material, serving demo batches, proof of principle, and preclinical studies. Seamlessly transferring technology to larger scales and ensuring GMP-compliant manufacturing is a pivotal aspect of our offering.

Analytical Solutions

Leveraging a wealth of experience, our analytical specialists expedite the transformation of your molecule from conception to clinical stages and beyond with unwavering success. Complemented by abundant capacity and diverse analytical insight, we provide our clients unparalleled access to a team of genuine problem solvers well-versed in the entire product life cycle. With an arsenal of cutting-edge analytical and synthetic equipment, we excel in conducting meticulous impurity identification for drug substances.

Route Scouting

Pioneering Efficiency Route scouting is foundational in identifying a safe, efficient, and cost-effective synthesis process for large-scale production. Key questions encompass safety considerations, raw material availability and affordability, patent implications, intermediate stability, purification methods, environmental concerns, and alternative routes derived from thorough literature reviews. Regulatory compliance is also weighed, shaping decisions that optimize time, cost, and quality. Our approach integrates these crucial aspects to formulate an optimized route.

Analytical Support

Our integrated analytical support entails method development and synthesizing and purifying analytical standards to empower accurate analysis and quality assessment.

Our proficiency extends across diverse domains, encompassing

Our Impurity Identification Solutions Encompass

Contact Us


Aryastha Life Sciences Private Limited, ARx,
Synergy Square II, Genome Valley, Shameerpet, Hyderabad,
500078, India

+91 91547 82433


Aryastha Life Sciences, Inc.
One Broadway, 14th Floor
Cambridge, MA 02142