January 7, 2023

Chemistry, Manufacturing and Controls (CMC) for Cell & Gene Therapy (CGT) Products

Cell and gene therapies for treating multiple myeloma, such as CAR-T, have resulted in breakthrough health outcomes for patients. In the last decade, approval of cell and gene therapy (CGT) products has increased significantly. Multiple other products are in clinical development for solid tumors, genetic deficiencies, and infections that promise more effective […]
January 6, 2023

Your Company’s FDA Meeting Survival Guide

Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
October 20, 2022

Why You Should Consider a Biologics Consulting Service

Biologics are complex molecular entities that require extensive planning and development strategies to control development costs, ensure compliance with regulations, and speed up a product to commercialization. Hiring a biologics consultant ensures you receive expert advice and support throughout the entire CMC development process. In this article, we will outline why you should consider a biologics consulting service and what benefits this will have for your company.
October 14, 2022
Investigational Device Exemption Study

What Is An Investigational Device Exemption Application and Study?

An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval. IDE applications support several types of studies: to […]
October 13, 2022

What Role Does ERP Play in Supply Chain Management?

Supply chain management is fundamental to business success. The past few years have demonstrated the importance of robust supply chain processes, from the security of raw materials to the optimization of business processes to maximize operational efficiencies.
August 30, 2022

How Pharma Companies Manage Commercial Supply Chains

The pharmaceutical supply chain is a complex network of processes that must work together to ensure patients receive vital medicines promptly and safely. Supply chains can be challenging, but managing them well is the key to successful pharmaceutical business.