Regulatory Due Diligence Services.
What is Regulatory Due Diligence?
Mergers and acquisition deals inherently carry a high degree of risks but those in tightly regulated industries with little tolerance like pharma can potentially carry some of the highest.
This necessitates a specific and rigorous form of due diligence that examines an organization’s regulatory compliance along with it’s stakeholders such as its agents, vendors/suppliers and partners, to identify risks and provide consultative advice on any further actions.
The specific type and nature of the due diligence will depend on the development stage of a particular product or portfolio of products, and the target market.
How Arriello provides a perfect regulatory due diligence solution.
On commencement we assign a project lead and team to establish, communicate and ensure a clear and rapid process is followed which is relevant to the asset(s) being acquired. Exactly what is reviewed will of course be dependent on the stage of development, type of product(s) and target market parameters, but typically we cover at least the following aspects:
- Review of the CMC documentation.
- Non-clinical and clinical studies already undertaken or planned.
- any Post-approval commitments.
- Any Sunset Clause issues.
How the regulatory due diligence service is then performed can vary, but usually we are used to being given access to a ‘data room’ to complete the process by a set deadline.
Arriello will then deliver its due diligence report which will highlight all the significant concerns and any other areas for further investigation.
The report will also include our consultative advice on next steps or further considerations, and we would normally take the initial opportunity discuss our findings face-to-face or via a call.
Selected Regulatory Affairs Case Studies.
What our clients say about us.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
