PRECLINICAL & CLINICAL SERVICES

Preclinical and Clinical Services
Mumbai Biocluster supports the development pipeline through preclinical and clinical services, including in vitro and in vivo studies. They work closely with industry partners to provide data-driven insights that accelerate the clinical trial process and enhance drug safety profiles.

Our Services Includes
01
DS/DP for Safety/Tox Studies
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GMP and Non-GMP Manufacturing of Drug Substance (DS)
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Analytical Method Development and Validation
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Supply Chain Management and Logistics for Preclinical Studies

03
Stability Studies for Preclinical Batches
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Stability studies on clinical-stage products to assess their shelf life, potency, and safety under various storage conditions.
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Long-term, accelerated, and stress testing, along with providing GMP-compliant storage solutions for clinical materials.


02
Clinical Stage Manufacturing
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GMP Manufacturing of Clinical Batches
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Scale-Up and Technology Transfer
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Aseptic Fill-Finish Services
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Stability Studies and Storage
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Regulatory Documentation and Support

04
Formulation Development for Preclinical Studies
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Formulation development services tailored to the needs of safety and toxicology studies.
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Creation of stable, bioavailable formulations that can be used in animal studies to assess the safety profile of the drug candidate.