How Mergers & Acquisitions Impact Regulatory Operations Part II
In Part 1 on this topic, I provided a framework for why companies out-license and in-license of products as well as the type of information that will be exchanged. In Part 2, I will discuss best practices, strategies, and the tools used during my experience.
MS Excel is a tool that I have found most reliable for developing the inventory listing. Excel can be used to inventory the documentation, export/import information to a database (in a tab delimited format), and then validate/verify the received inventory.
The spreadsheet will include such information as date of document/submission, submission number, document/submission type, description, and other data deemed valuable for the product history. Another suggestion is to keep an overall list of the products. This spreadsheet might include the product name and dosage, the type of submission (NDA, ANDA, IND, etc.), the status of the submission, the regulatory agency/division, etc.
Once the inventory is collected, inventoried, and ready for transfer, the next step is to find a good method for the interchange of the inventory. There are many good methods to choose from including eRooms, portable hard drives, CD/DVD, FTP/SFTP sites, and of course the legacy paper being shipped via courier.
Once the inventory of product documentation is received and verified electronic submissions must be quickly integrated into the corporation’s eCTD publishing tool. This can be challenging. I suggest utilizing the expertise of the vendor. Vendors know their software much better than most RegOps staff and can be quite useful in integrating the submissions quickly into the publishing system.
Hard copy documentation must be assessed for future use. A decision should be made to scan the documents or merely validate the inventory and store the documents. If the decision is made to scan the documents, do so in black and white to keep file size to a minimum (gray scale and color scanning usually results in a larger file size).
It is important, during the process of in/out-licensing, to include Information Technology staff in the process of collecting and receiving documents and data. Information Technology staff can be quite useful by ensuring the clean transfer and permanent storage of documents for out-licensing and smooth acceptance and storage of documents during in-licensing. Information Technology staff will ensure there is sufficient drive space and networks are not bogged down, important logistical requirements for the acceptance of a large inventory of documentation and data. Information Technology will also ensure that the security settings for folders are properly set.
Strategies for ensuring all of the above is done with little interference starts at the top. Executive management may consider creating a strategic plan for in/out-licensing and mergers and acquisitions. This strategic plan should include the technical aspects of such an undertaking. Such topics as systems to be used, network and security, and staff involvement (including when to involve staff) are important strategies to ensure success.
Additionally, it is recommended that RegOps and Information Technology collaborate to create a strategic plan for the necessary tasks they will have to perform during these activities. A full understanding of the corporate systems and processes is vital to the success of the integration and divesting of products. This information is important to ensuring the newly acquired information is quickly integrated into the corporate system and that information being sent during a divestiture is quickly gathered.
To ensure success a few high level recommendations are suggested:
- Ensure the current practices work whether they be methods for storage or publishing practices.
- Involve RegOps and IT early in the process to ensure quick and accurate collection of inventory.
- Be flexible and scalable not just in the technology but also in the utilization of staff and outside assistance.
- Use contractors, temps, and vendors when necessary.
- Integrate new staff quickly (6 months or less is a good practice).
- Understand and leverage the expertise and knowledge of staff, including newly acquired staff.
- Processes, tools, and management may change, be prepared to manage the transitions.
- Understand that there will be stressful times during the process. Recognize the signs of stress and handle them quickly.
- Remember that people are a corporation’s most valuable resource, keep them informed and let them know they are important to the success of the current undertaking.