GlobalSubmit Blog: Mergers and Acquisitions, A Regulatory Operations Perspective – Part I – By Rachel A. Wagner

I had the great privilege of speaking at the DIA eCTD conference this past November. The subject of my talk was on the out-licensing and in-licensing of products. Many of you may have had to undertake these tasks in the recent past as this has become a frequent occurrence in our industry. This is the first entry of a two part post where I will share my experiences during the past year including the issues and lessons learned.

The purpose of out-licensing is to raise money for the corporation, or to divest a developed technology. During the out-licensing process it is necessary for the RegOps group to organize and transfer the information and documentation to the new company. This may include the submissions, labeling, correspondence, and other documentation for the product. Additionally a chronology of the product documents, whether that be hard copy, electronic, or both should be included as an “inventory” check.

In-licensing is accomplished to add new products to the corporate pipeline, and procure resources needed for final-stage development, clinical trials, manufacturing, and distribution of products. It should be noted that with any in-licensing there will be a large amount of incoming inventory (documentation) and there is normally an urgency to integrate and streamline the information being received. The documents must be added to the corporate network folders, the EDMS, the publishing system, or other storage methodologies. This must be done quickly and accurately.

To find more information please click here: GlobalSubmit Blog:  Mergers and Acquisitions, A Regulatory Operations Perspective – Part I – By Rachel A. Wagner