Prescription Drug Evolution - Kendall Life Sciences - clinical trials
Specialized Life Sciences Consulting Group

Kendall Life Sciences Prescription Drug Evolution

Prescription Drug Evolution

How our team can guide you through the entire journey
klifesciences-ind-submissions
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IND Submission
 

Traditionally, drug development begins with the identification of an appropriate chemical or biologic molecule or compound.

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Kendall Life Sciences - After obtaining required regulatory approvals, clinical trial work may begin. Clinical trials are generally divided into formal “Phases” each with varying obligations and endpoints
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Clinical Trials
 

After obtaining required regulatory approvals, clinical trial work may begin. Clinical trials are generally divided into formal “Phases” each with varying obligations and endpoints.

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The regulatory requirements that govern the contents of an NDA are intended to give FDA enough information to make a meaningful evaluation of a drug
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New Drug Application (NDA)
 

The regulatory requirements that govern the contents of an NDA are intended to give FDA enough information to make a meaningful evaluation of a drug.

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Kendall Life Sciences LLC - regulatory approval - All NDA applications must meet the basic substantive requirement that the drug is both - safe - and - effective
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Regulatory Approval
 

All NDA applications must meet the basic substantive requirement that the drug is both “safe” and “effective”.

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Kendall Life Sciences LLC - Post Approval The approval of an NDA submission creates new obligations and responsibilities for the NDA holder
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Post Approval
 

The approval of an NDA submission creates new obligations and responsibilities for the NDA holder.

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Kendall Life Sciences LLC - Life Cycle Management - The management of a drug life’s cycle begins with the identification of an appropriate chemical or biologic molecule or compound in the Pre-IND phase
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Life Cycle Management
 

The management of a drug life’s cycle begins with the identification of an appropriate chemical or biologic molecule or compound in the Pre-IND phase.

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