Regulatory Approval

Prescription Drug Evolution

How our team can guide you through the entire journey

All NDA applications must meet the basic substantive requirement that the drug is both “safe” and “effective.” The FDA “weighs the product’s demonstrated effectiveness against its risks to determine whether the benefits outweigh the risks.” Additionally, there must be adequate manufacturing controls in place before the FDA will approve a drug, including compliance with FDA’s current Good Manufacturing Practice (CGMP) requirements. The drug’s labeling must also meeting applicable statutory and regulatory requirements.

The Challenge

While an NDA applicant must focus on the NDA requirements in order to achieve regulatory approval, the applicant must also consider other regulatory issues in the event of drug approval. For example, there are numerous naming considerations a company faces in the process of creating a drug’s name including the safety review or proposed proprietary name through the Division of Medication Error and Prevention Analysis (DMEPA) and Office of Drug Promotion (OPDP), FDA Draft Guidance regarding proprietary names, marketing metric research and linguistic evaluation, regulatory and name safety trademark and health authority name submissions.

The Strategy

KLS’ experts understand the challenges surrounding both the standard of review requirements and other considerations NDA applicants face upon regulatory approval, including the process of developing a proprietary drug name. KLS is well versed in the process of developing the proprietary name for a drug product and is able to assist companies in piloting this process. KLS is well equipped to address the complexities surrounding the regulatory approval process and will work directly with your team to navigate these complexities to achieve successful regulatory approval.

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.

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.

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.

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.