New Drug Application - Kendall Life Sciences LLC
Specialized Life Sciences Consulting Group

New Drug Application (NDA)

Prescription Drug Evolution

How our team can guide you through the entire journey

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. The specific NDA data requirements are lengthy and detailed, covering several broad categories: 1) preclinical data; 2) human pharmacokinetic and bioavailability data; 3) clinical data; 4) a description of proposed methods by which the drug will be manufactured, processed and packed; 5) a description of the drug product and drug substance; 6) a list of each patent claiming the drug, drug product or method of use, or a statement that there are no relevant patents making such claims; and 7) the drug’s proposed labeling. The NDA must also contain various regulatory certifications and may require risk evaluation mitigation strategy (REMS).

The Challenge

In addition to meeting the specific data requirements and REMS, applicants face several other requirements and hurdles in their submission of the NDA application. The Prescription Drug User Fee Act (PDUFA) levies a user fee on certain human drug applications. Additionally, the FDA will only receive an NDA application for filing if it is sufficiently complete to permit a substantive review. If an NDA application fails to meet this standard, the FDA may also utilize its authority to refuse to file (RTF) the NDA application.

The Strategy

Careful planning and preparation is key in successfully submitting a drug application. KLS’ industry experts can provide the necessary experience and insight to counsel and assist in the preparation and submission of an NDA application so that the NDA is successfully filed by the FDA for review. KLS can also provide valuable counsel to companies in the development of goals and timelines for PDUFA fees and submission, including complete response letter(s) and resubmission(s) and/or requested end-of-review conference(s), if applicable.

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.

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

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

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.