IND Submission - Kendall Life Sciences LLC
Specialized Business & Compliance Consulting Group

IND Submission
 

Prescription Drug Evolution

How our team can guide you through the entire journey

IND Submission

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Traditionally, drug development begins with the identification of an appropriate chemical or biologic molecule or compound. Preclinical data (chemical analysis and animal trials) are used to begin building the product profile. The results of these preclinical tests are used to support an application to the FDA seeking approval to use the new molecule or compound in clinical trials (the Investigative New Drug application (IND)). As part of the IND, applicants must provide details regarding proposed manufacturing and controls and proposed clinical trial protocols.

The Challenge

The sheer volume of data required to support an IND can be overwhelming to those unfamiliar with the process. Additionally, what is often over looked during this early stage, is ensuring that all materials supporting the future product will be generated with an eye towards eventual commercialization efforts. All too often the long term success of the product is dependent on the foresight of the team developing the IND and associated materials.

The Strategy

It is important to achieve and maintain productive and active communication with the FDA during the IND (as well as any other) phase. KLS can help ensure productive dialogue between product sponsors and the FDA. KLS’s team of experts have experience commercializing drug products and understand first-hand how to maximize value during the IND development phase.

Specialized Business and Compliance Solutions

Your industry experts are here.  You call, we listen.  We take a personalized approach to help you prevent and solve problems.
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Commercial Operations

This department manages some of the industry’s most high-risk areas. Our team understands that commercial initiatives are often critical for success, but the monitoring and oversight process can be difficult in practice.
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Sales & Marketing

Life sciences sales and marketing departments face a number of challenges not present in other industries. Developing effective yet risk appropriate sales and marketing strategies in the life sciences industry is often a long and difficult process.
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Regulatory & Compliance

Life sciences companies face compliance and regulatory requirements and restrictions unique to their industry.
Often times a long-term vision of the compliance/regulatory landscape is necessary to ensure that commercialization strategies
are fully achieved.
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Leading Minds
in Life Sciences

We are a core group experts across the spectrum of life sciences disciplines that provide clients with maximum value.

Delivering Measurable, Sustainable Results

We adopt a unified, holistic approach to a broad range of compliance and regulatory challenges.

More Than Experts
– Partners for Success

Our team takes the time to understand each client’s unique business objectives, operations and long-term vision to successfully solve problems, avoid risk and accomplish tasks correctly the first time.