Getting Medicines to Market Faster

Due Diligence / Gap Analysis

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:

  • Is incomplete!
  • Is out of step with current guidelines!
  • And/or there is no consistent record of what has been submitted to Health Authorities! 

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.

CambReg’s Due Diligence Service

We cover the full range of product types including biotechs, small molecules, generics, and orphan drug.  Our activities fall in to two main categories:

Review of the Registration Dossier

For dossiers before registration and for products already commercialised, a review would aim to indentify and record:

  • Dossier completeness
  • Any formatting  issues (electronic, CTD)
  • Compliance with current EU guidelines / legislation
  • On-going regulatory issues (pending variations,)
  • Any outstanding regulatory commitments (eg stability data)
  • Compliance of Product Information (PI)
  • Regulatory actions required

Results can be presented in a report format and / or Registered Technical Details (RTDs) can be generated for the product as necessary.

Audits or mock-inspections

  • Active substance manufacturers
  • Finished product manufacturers
  • EU import, batch testing and release sites
  • Distributors
  • External suppliers (e.g. Pharmacovigilance Services)

Our experience can help you

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.

References

  1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use

Official Journal L – 311, 28/11/2004, p. 67 – 128