ISLL CRAMS - Spectrum of services


Drug Development

Early phase development of NCE, Intermediates or Key Starting Materials for Toxicity studies and for clinical phase supplies by process research, development and supply of material along with GMP/CMC documentation suitable for the phase.


Process research and development

Cost competitive, operationally feasible, eco friendly, Regulatory and Intellectual Property compliant processes


Contract Manufacturing

Accommodation of process at appropriate scale, DMF update/support, regulatory compliant commercial manufacturing of Intermediates and API with YOY cost reduction.


High Potent API manufacturing

We also have a category-3 Safebridge equivalent High potent active ingredient manufacturing site accredited by EDQM,TGA,WHO and US FDA.


Custom Chemical synthesis

Advance Intermediates and Specialty chemicals


FTE Model

For mutually agreed target compounds, processes, analytical services, CMC documentation and IPR support


Analytical Services


Regulatory Submission Support (CMC)



Capability and Capacity Matrix
Volumes
Intermediates
KSM / RSM
API
Small
Appropriate GMP
cGMP
cGMP
Medium
Appropriate GMP
cGMP
cGMP
Large
Appropriate GMP
cGMP
cGMP

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