Regulatory Strategy Consulting

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To gain approval for clinical testing after finalizing the pre-clinical testing of innovative new therapies, it is a key milestone for pharmaceutical companies to apply for approval of Investigational New Drug (IND) with FDA or other agencies.https://www.creative-biolabs.com/immuno-oncology/regulatory-strategy-consulting.htm

Regulatory Strategy Consulting

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The elegant design of an antibody-drug conjugate is designated to achieve targeted delivery of the conjugated cytotoxic agents to tumor cells and drug release upon antigen binding and internalization, thus maximizing the antitumor effects while minimizing cytotoxicity to normal tissues. The efficacy of an ADC greatly depends on the specific antigen binding activities of the monoclonal antibody (mAb) portion of the molecule.https://www.creative-biolabs.com/adc/adc-affinity-measurement.htm

ADC Affinity Measurement

ADC Affinity Measurement

ADC Affinity Measurement

adc adcc

Development of 5T4-based Bispecific ADCs A bispecific antibody can bind two different targets or two distinct epitopes on the same target. 5T4, specifically overexpressed on the cell surface of various tumors and internalized rapidly when bound to antibody, may be used as an attractive target to develop effective immunotherapy such as bispecific antibody-drug conjugate (ADC). https://www.creative-biolabs.com/adc/development-of-5t4-based-bispecific-adcs.htm

5t4 adc

Modality

IND Publishing and Submission

IND Publishing and Submission

IND Publishing and Submission

Pre-IND Meeting

Pre-IND Meeting

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✔ Clinical overviews (eCTD Module 2.5) including literature review and references ✔ Clinical summaries (eCTD Module 2.7) including clinical pharmacology, efficacy, and safety ✔ Clinical study report preparation and review (eCTD Module 5) ✔ Clinical justification documents for EU, US and other emerging Regulatory markets ✔ Gap analysis for dossiers in clinical module ✔ Clinical and nonclinical document support, handling queries during HA meetings and responding to them ✔ Technical review dossiers ✔ Biowaiver support and justification document services https://www.creative-biolabs.com/immuno-oncology/medical-writing-and-translation.htm

Medical Writing and Translation

Medical Writing and Translation

Medical Writing and Translation

IND Regulatory Services

IND Regulatory Services

IND Regulatory Services

cGMP Manufacturing

cGMP Manufacturing

cGMP Manufacturing

Antibody and Protein Toxicology

Antibody and Protein Toxicology

Antibody and Protein Toxicology

Antibody and Protein Pharmacology

Antibody and Protein Pharmacology

Antibody and Protein Pharmacology

Efficacy Models

Efficacy Models

Efficacy Models

Drug discovery and development pathway is a long journey, and complications and inefficiencies at the late stage can create costly delays. Therefore, safety and efficacy profiles assessments of drug candidates prior to clinical trials are critical stages to avoid unnecessary loss. Preclinical testing in animal models can help to foreseen potential risks of drug candidates before exposure to humans, and hence reduce the cost for pharmaceutical industries and help to make the appropriate choice.https://www.creative-biolabs.com/immuno-oncology/preclinical-testing.htm

Preclinical Testing

Preclinical Testing

Preclinical Testing

Drug stability studies are an important part of the drug development and life cycle, especially in support of development and IND submission activities. The stability test assesses how the quality of the drug substance or drug product or its packaging changes over time under the influence of environmental factors including temperature, humidity and light.https://www.creative-biolabs.com/immuno-oncology/stability-analysis.htm

Stability Analysis.pdf

Stability Analysis.pdf

Stability Analysis.pdf

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IND Publishing and Submission.pdf

IND Publishing and Submission.pdf

IND Publishing and Submission.pdf

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Pre-IND Meeting.pdf

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Medical Writing and Translation.pdf

Medical Writing and Translation.pdf

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Regulatory Strategy Consulting.pdf

Regulatory Strategy Consulting.pdf

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IND Regulatory Services.pdf

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