Overview
In the 1990s, diversified product portfolios across medical devices, small molecules, generics, biologics, and branded drugs illustrated value. However, in recent years companies have realized the potential of having a concise product portfolio and implementing strategies with simplicity at its core. This shift in the trend was witnessed in the consolidation of 60 major life sciences companies into, 10.
Pharmaceutical organizations must conduct major modifications right from the Regulatory to the end-product packaging and labeling domain for the product(s) they support. Multinational Pharmaceutical firms face much more complex scenarios, as they perform multiple product transfers. To drive these modification initiatives towards a successful execution, the organization should ensure a constant evaluation of their activities and processes and ensure they are in alignment with their company’s end goals.
As most organizations fail during the initial phase of such product transition deals/decisions due to incorrect approaches, and/or unforeseen circumstances, establishing a governance plan at the get-go is crucial. To avoid errors from the beginning and at any given time of the process, organizations must ensure that they implement management plans at initial governance stage to manage the transition procedures.
Establishing a Transition Management Office (TMO) will help organizations track their progress during the transition phase through a single point of contact. A TMO framework must ensure that:
- Transition road maps are designed from a Regulatory standpoint
- Strategize every phase and step involved in the transition
- Deals made during the process are impartial towards any merging or divesting entity
- Develop a resilient framework of operation for participating entities
- Visibility on progress is available for all stakeholders during the transition period
- Necessary documentation tasks are to be kept up to date
Freyr’s Spin-offs, Mergers & Acquisition, and Divestitures (SoMAD) Consulting services:
A successful Spin-off, Merger, Acquisition, and/or Divestiture is best supported by a resilient framework and a strong pharmaceutical technology transfer plan. A system that not only keeps up with the dynamism of the processes but is also adapted to changing strategy with the unfolding hierarchy of requirements.
At Freyr, our Regulatory Strategy Consulting team understands the ins and outs of the pre-, during, and post-transition processes. Our SoMAD segment serves as a Transition Management Office while the companies establish their new identity.
Freyr understands that every company and their needs are different. Our team can best help and support your company as you undergo the transition.
Our Expertise Ranges Across
- Global organizational setup as per Health Authority obligations
- Future-proof market entry plan with local support in over 120+ markets
- Marketing authorization transfers with industry-leading turnaround time
- Go/No-Go decision and due diligence
- Plug and Play infrastructure of resource deployment
- Post-transition management services
Throughout the transition journey, Freyr is well equipped to provide end-to-end Regulatory support to ensure the smooth running of processes, from a complete handover to the new entity, all authorizations, and positions of responsibility as and when ready.
Key Considerations for NewCo (New Entity Formation)
New Product Introductions
Evaluate:
- Evaluate the current strategies for product launch in selected markets; revise as needed
- Managing or maintaining AR during transition; identifying strategies or evaluating the current stance
- Launch of current projects (in motion) vs. future strategies and its congruent Reg_ intelligence support analysis
Technology Harmonization
Evaluate + Consult:
- Interim and Future approach for sharing, and owning technology application licenses
- Application licenses for managing regulatory data
Services Offered by Freyr
