Post Approval - Kendall Life Sciences LLC
Specialized Business & Compliance Consulting Group

Post Approval
 

Prescription Drug Evolution

How our team can guide you through the entire journey

Post Approval

www.klifesciences.com_Post_Approval-large

The approval of an NDA submission creates new obligations and responsibilities for the NDA holder. The FDA may require the NDA holder to conduct post-approval “Phase IV” studies to: 1) obtain additional safety data, 2) obtain additional efficacy data, 3) detect new uses for or abuses of a drug, or 4) determine effectiveness for labeled indication under widespread usage. The NDA holder also must engage in pharmacovigilance processes directed toward detecting, assessing, understanding and preventing adverse events or other product-related problems. Additionally, the NDA holder must take steps to determine what forms of market protection, if any, are available and begin to commercialize the prescription drug product.

The Challenge

As in pre-NDA approval clinical trials, “Phase IV” studies are subject to strict legal and regulatory requirements and controls and adherence to these requirements and controls is vital to the studies’ success. The current pharmacovigilance landscape requires sophisticated infrastructures to aid NDA holders in quickly and aggressively obtaining and reporting adverse events. The proper selection of one of the various statutory market protection avenues is vital to the long-term success of a prescription drug product. The commercialization of a prescription drug product includes multiple considerations each with its own complexities including promotion, insurance formularies, federal and state drug pricing regulations, and government programs. NDA holders must understand the intricacies within each of these challenges in order to successfully navigate the post regulatory approval landscape.

The Strategy

KLS’ experts understand the various complexities and nuances of the challenges face after NDA receive regulatory approval. KLS has the experience and the industry knowledge to assist your team in each challenge and component of post regulatory approval. KLS will work directly with your team to provide the necessary experience and insight so that your team is able to achieve success in the post regulatory approval landscape.

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.
klifesciences-online-business-icon

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.
Read More
klifesciences-presenter-icon

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.
Read More
klifesciences-checklist-icon

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.
Read More

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.