cGMP Supplies for TOX & Clinical Studies
At CRAMSN Research Park, we offer cGMP-compliant (Current Good Manufacturing Practice) services for the synthesis and supply of materials required for TOX (Toxicology) and Clinical Studies. Our state-of-the-art facility ensures that every batch is manufactured under the highest quality standards, meeting regulatory guidelines to support your development from preclinical studies to clinical trials.
We specialize in a variety of critical assessments and studies necessary for preclinical safety testing, clinical trials, and regulatory submissions. Our comprehensive services include
PDE/OEL Assessment
Assess safety limits for handling potent compounds, ensuring safe working conditions with occupational exposure limits (OEL) as low as 0.1 µg/m³.
Fit for Process Optimization
Optimize manufacturing processes for scalability, efficiency, and reproducibility, ensuring smooth transition from lab-scale to clinical production.
Scale-Up Studies
Transition from small-scale synthesis to full-scale manufacturing while maintaining quality and consistency of the drug product.
Process Study
Evaluate and optimize process parameters to ensure robust and reproducible manufacturing processes, ensuring compliance with cGMP standards.
Safety Studies
Conduct preclinical safety studies (acute, sub-chronic, and chronic toxicity) to assess the safety of drug candidates before human trials.
Preliminary Stability Study
Evaluate the stability of drug substances (DS) and drug products (DP) under different storage conditions, ensuring proper shelf-life and stability during clinical trials.
PSD/Polymorph/ Morphology Studies
Analyze particle size distribution (PSD), polymorphs, and morphology of drug substances to enhance bioavailability, solubility, and stability.
Analytical Research & Development
Develop and validate methods for testing purity, stability, and potency of drug substances and drug products through techniques like HPLC, GC, and Mass Spectrometry.
Synthesis and Supply
Provide cGMP-compliant synthesis and supply of high-quality API and drug products for toxicology and clinical trials.
NA (Nitrosoamines) & GTI (Genotoxic Impurity) Assessments
Assess and quantify nitrosoamines and genotoxic impurities in drug substances and products to ensure safety for clinical use.
Elemental Impurity Assessments
Evaluate and quantify elemental impurities in drug products per ICH Q3D guidelines, ensuring safety for human clinical trials.
Why Choose CRAMSN Research Park for cGMP Supplies?
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End-to-End Services: From synthesis to clinical trial support, we provide complete solutions for your drug development needs.
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cGMP Compliance: All processes adhere to cGMP standards, ensuring top-quality materials for clinical trials.
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Advanced Facilities: Equipped with the latest technologies and instruments for every stage of development.
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Regulatory Expertise: In-depth knowledge of global regulatory guidelines, supporting your IND submission and clinical trial needs.
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Tailored Solutions: Customized services to meet your specific drug development and regulatory requirements.
