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Process R&D

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  • Process Research and Development

From Process Development to Scalable Delivery

At Zasya Life Sciences, we specialize in phase-appropriate process development, ensuring successful scale-up and timely delivery of high-quality products for clinical trials. With a focus on innovation, safety, and sustainability, our experienced team delivers efficient solutions tailored to your drug development needs.

Why Choose Zasya for Process Research and Optimization?

Why Choose for Process Research and Optimization?

Extensive Expertise

Skilled in handling complex chemistry, hazardous reagents, and advanced intermediates.

Modern Infrastructure

Equipped with parallel synthesizers, autoclaves, reactors, along with dedicated analytical capability

Comprehensive Approach

Expertise in route scouting, impurity profiling, solvent selection, and alternative reagents screening.

Scalability

Capability to handle processes from lab-scale to pilot scale, ensuring seamless transition to large-scale manufacturing.

Regulatory Insight

Support for analytical method development, reference standard qualification, and regulatory-compliant stability studies.

  • In the early stages, our focus is on accelerating the drug development journey by:

Early Phase Development

Quality Assurance

Conducting thorough route scouting and screening alternate reagents, catalysts, and solvents.

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Designing processes with reduced steps and timelines for faster clinic readiness.

Stability studies

Leveraging DoE (Design of Experiments) and QbD (Quality by Design) to identify critical process parameters and establish robust methods.

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Running demonstration batches in our non-GMP kilo labs to minimize GMP-scale risks.

  • For late stages, we ensure a seamless transition to commercial manufacturing by:

Late Phase Development

drug discovery

Conducting detailed experiments to optimize processes.

Accurate Results

Performing confirmatory lab batches to validate product yield and quality.

Stability studies

Utilizing intermediate-scale facilities for challenging scale-ups before moving to full-scale production.

Quality Control

Backward integration, salt screening, and polymorph evaluation to enhance reliability.

Analytical and Regulatory Support

Advanced Instrumentation

Development and validation of stability-indicating methods and reference standard qualification.

Experienced Team

Comprehensive impurity profiling, characterization, and synthesis of reference standards.

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Stability studies as per guidelines for NCEs to meet regulatory requirements under non-GMP conditions.

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Dedicated analytical team ensuring speed and accuracy in process development activities.

Scalable Solutions with Fast Turn-around-time

Zasya offers scalability from lab-scale to pilot-scale and manufacturing campaigns, providing consistent and reliable processes at any scale. With the ability to deliver 500 g to 1000 kg in record time, we ensure your project progresses with agility and precision.

Partner with Zasya Life Sciences for innovative process research and optimization services that are robust, compliant, and tailored to your development goals.

  • Partner with Zasya for Advanced process research and optimization services.
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