Strategic Divestments: Maximising Product Lifecycle Value

Maximising Divestment Value for Reinvestment

DLRC offers end-to-end regulatory services from pre-marketing support to post-marketing management and beyond. A company’s business growth strategy may involve product divestiture to maximise partnerships and support mergers and acquisitions. DLRC successfully managed multiple products post-approval for a large pharmaceutical company. The company then tasked DLRC with overseeing its entire portfolio of planned and ongoing divestment projects.

DLRC support in divestment includes supporting the client during the public offering. They respond to questions in due diligence and provide regulatory input into the contract negotiation where needed. However, by far, the largest area of activity is helping to ensure that the global marketing authorisations are transferred to the buyer per the agreed timelines and with minimum disruption to supply and continued lifecycle management. The target is a seamless transition in the marketplace.

Variety Across the Globe

Marketing Authorisation transfers vary widely across the globe. Building accurate, current, and detailed knowledge for every market from Albania to Zimbabwe would be challenging. DLRC has built up knowledge from experiences working with local markets. However, with a continuously changing regulatory environment, the value of local regulatory expertise is crucial for success.

It is often assumed that the responsibility for the transfer rests with the buyer .DLRC experiences highlight a global variation in the responsibility for the process that could rest with the buyer, the seller, or both. If you ask a group of markets the same question, a third would say the buyer, a third would say the seller and a third would say that it’s a joint submission! The important thing is, therefore, not to take anything for granted and to utilise local expertise wherever possible.

Nevertheless, DLRC continually collates local knowledge and analyses the impact of specific local market requirements. For example, which markets require a regulator appointment to submit and how long it might take to get such an appointment. Where Certificates of Pharmaceutical Products (CPPs) are required, our experience has shown that not all the information requirements are published but are often requested during the process.

Collaboration is Key

Of course, projects of this size are not possible without close interaction with other functions. The supply chain needs to plan the bridging stocks based on the expected demand and the permitted grace period. Often the buyer will have longer lead times on production to consider in the transfer timing. How long old MA holder details can be on packaging within the supply chain following transfer varies, and strategic planning alongside negotiation with the regulators to ensure there are no out of stock scenarios.

In addition to all transfer activities, the normal lifecycle activities must continue and often compete with the divestment requirements. A renewal might need to be submitted in 8 months, and the transfer (which will take around six months) cannot be submitted while the renewal is ongoing. DLRC works with the client and partners to evaluate the benefits and risks and determine the optimal strategy.

Divestment Support You Can Trust

The end of a product’s lifecycle can present some demanding and challenging regulatory strategies. This creates the need to navigate varied global requirements while continuing to meet the supply of products to patients.

We are delighted to offer our expertise in regulatory support for this sector and others. With over 1,000 years of cumulative regulatory experience, our team is well-prepared to address your needs, having likely encountered similar challenges. Contact us to find out how we can assist you, by emailing us at hello@dlrcgroup.com or using the link below.