Global portfolio Due Diligence

A big EU pharmaceutical company engaged in developing, manufacturing and commercializing a broad variety of medicinal products, interested in acquiring a whole set of worldwide brands from a company, but lacking the specific local regulatory knowledge for the audit of dossiers in certain countries.

The project presented the following challenges:

• Over 125 MAs in more than 25 countries in scope of the due diligence (DD)
• Set-up of a multidisciplinary and integrated team, together with external local regulatory experts with sound knowledge in dossier quality, as well as regulatory procedures and regulatory intelligence
• Reduced time for documentation review, what required of high flexibility and adaptability (time-critical)
• Strategic consultancy on MA status for future company investment

The activities performed by Asphalion included:

• Dossier quality review in compliance with national guidelines and regulations and with ICH guidelines
• Regulatory intelligence and clarification on local requirements (such as the need of local representation, distributors, manufacturing sites and MA transfer/variations fees and timelines)
• Executive summary report of material findings and red flags in current MAs per country
• Comprehensive product specific reports

Successful Due Diligence:

• Assessment of dossier compliance
• In all requested countries
• Within timeline goal
• Within agreed budget

This allowed the Client to make an informed decision about the portfolio acquisition.