Kendall Life Sciences Prescription Drug Evolution

Prescription Drug Evolution

How our team can guide you through the entire journey

IND Submission

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

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.

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.

Regulatory Approval

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

Post Approval

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

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.