How Mergers & Acquisitions Impact Regulatory Operations Part 1

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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.

The merger/acquisition of companies brings the same type of product on-boarding to a corporation along with the integration of staff and possibly the integration of divergent systems.

There are many tools and methods to make these challenges and opportunities less difficult. These tools will be used to transfer information, inventory documents, and validate the received inventory.

Transfer of Documents

Transfer of documentation should be done in a logical structure. To this end it is important to create a folder structure that is logical to follow. One suggestion is to create a folder structure that includes such a format as:

  • Product
    • Country
      • Submission Type
        • Submissions
        • Correspondence
        • Labeling
        • Data

If the corporation does not already have a logical folder structure for storing the inventory of documents that are vital to a product portfolio, I suggest starting that procedure prior to in/out-licensing. Waiting until the critical moment to do this is time consuming and will delay the timeline for completion of the project.

In part two of this topic I will discuss best practices, strategies, and the tools used during my experience.

Author: GuestPost

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  1. Mergers & Acquisitions Regulatory Operations - eCTD Summit - […] Part 1 on this topic, I provided a framework for why companies out-license and in-license of products as […]

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