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Pre-Clinical Development
Study Directors and Technicians work on studies related to Administration, Distribution, Metabolism and Elimination, using advanced technologies in Bio-analysis.
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Pharmaceutical Development
Pharmacists and Engineers manage all the Formulation and Analytical Development steps while respecting Good Laboratory Practices.
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Clinical Development
Galderma's R&D clinical trial managers, clinical trial monitors, statisticians, data managers, scientific writers and regulatory affairs managers work hand-in-hand in cooperation with different experts to set up a clinical development plan that meets the medical and regulatory requirements of different countries. Clinical trials are conducted in a highly regulated environment, including smaller mono-center trials for specific purposes, such as pharmacokinetics, dermatological safety trials, or early efficacy studies for dermatological indications. Larger studies include international multi-center trials to investigate dose ranges, regimen and confirm efficacy in the general population for a chosen indication. Phase I to III clinical trials are currently being conducted for over 20 projects involving new chemical entities, as well as formulation, dosage or other line extensions.
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Project Management
Galderma has chosen to adopt a Project approach to development and for this reason, all the above development activities are coordinated by Project Leaders.
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|
Pre-Clinical Development
Study Directors and Technicians work on studies related to Administration, Distribution, Metabolism and Elimination, using advanced technologies in Bio-analysis.
|
Pharmaceutical Development
Pharmacists and Engineers manage all the Formulation and Analytical Development steps while respecting Good Laboratory Practices.
|
Clinical Development
Galderma's R&D clinical trial managers, clinical trial monitors, statisticians, data managers, scientific writers and regulatory affairs managers work hand-in-hand in cooperation with different experts to set up a clinical development plan that meets the medical and regulatory requirements of different countries. Clinical trials are conducted in a highly regulated environment, including smaller mono-center trials for specific purposes, such as pharmacokinetics, dermatological safety trials, or early efficacy studies for dermatological indications. Larger studies include international multi-center trials to investigate dose ranges, regimen and confirm efficacy in the general population for a chosen indication. Phase I to III clinical trials are currently being conducted for over 20 projects involving new chemical entities, as well as formulation, dosage or other line extensions.
|
Project Management
Galderma has chosen to adopt a Project approach to development and for this reason, all the above development activities are coordinated by Project Leaders.
|
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