Any Business interested in working with FDA should be registered at SAM.gov and within the SBCX portal. Registering with SBCX will place your business within the Small Business Directory Tool...

Oct 31, 2024 · Are you a small business with questions about your FDA-regulated product? Or, do you wonder if your product needs to be approved by the FDA? Contact us!

FDA’s jurisdiction of products and activities is vast, ranging from over-the-counter drugs to infant formula, and the challenges to secure the safety of these products increases in complexity with a growing global market. What firms have been awarded IDIQ contracts? Which Blanket Purchase Agreements (BPA) are being most utilized within an agency?

Evaluation and Research (CDER) at the Food and Drug Administration (FDA) with information regarding target product profiles (TPPs). A TPP is a format for a summary of a drug

We present this document as a blueprint that firms can follow to achieve their business aims while helping FDA accomplish its public health mission. The first — and most basic — question that's often asked is this: why do some products and services have to be regulated?

Jan 7, 2025 · Understanding FDA compliance is an essential part of building a successful business in regulated industries but it doesn’t have to be daunting. By taking proactive steps—like registering your establishment, mastering labeling requirements, developing a food safety plan, and staying informed—you can set yourself up for success while ...

We offer insight on the nature of applications and the applicability of FDA “exclusivity” and patent provisions. When your product goes to market, we can review your promotional statements and product claims, as well as support any life cycle management issues you may face.

STRATEGIC PLAN AND IMPLEMENTATION OF A NEW BUSINESS MODEL The OLSS is currently in the process of developing a Strategic Plan for fiscal years 2017 to 2022, part of which is this framework. The plan will document the vision, mission, goals, and objectives of OLSS and place them in the context of FDA’s broader mission. It will describe

Mar 10, 2025 · A US FDA Quality Plan is a master blueprint to ensure that your products meet FDA regulations and industry standards. It is a strategic framework that aligns your operations with compliance requirements while keeping quality at the core.

Final Business Plan Model-Informed Drug Development General Principles Guideline Dated 27 October 2022 Endorsed by the Management Committee on 10 November 2022 1. The issue and its costs • What problem/issue is the proposal expected to tackle? Many regulatory authorities expect to receive, and currently accept model- based analyses as part