In the current climate, the ever increasing number of company mergers, acquisitions and in/out-licencing deals means that the area of Due Diligence is becoming more important throughout the pharmaceutical industry.
The Marketing Authorisation Holder (MAH) has ultimate responsibility for all its medicinal products marketed within the EU (1). We see the results of inadequate Due Diligence on a regular basis, finding, often at a late stage that the acquired dossier:
Penalties imposed by regulatory authorities on companies failing to ensure regulatory compliance have included fines, withdrawal of an MA, product recalls or disruption to product distribution at a regional level.
We cover the full range of product types including biotechs, small molecules, generics, and orphan drug. Our activities fall in to two main categories:
For dossiers before registration and for products already commercialised, a review would aim to indentify and record:
Results can be presented in a report format and / or Registered Technical Details (RTDs) can be generated for the product as necessary.
Our knowledgeable core team includes an ex Health Authority GMP inspector and an ex MHRA assessor and is thus able to tackle all aspects of Due Diligence with regards to human medicines. This means that we can truly view your material and operations with a ‘game keepers’ hat on.
In addition, we have an international network of tried and tested regulatory associates who can advise on Due Diligence matters worldwide.
Official Journal L – 311, 28/11/2004, p. 67 – 128