Due Diligence / Gap Analysis / Audits

The Marketing Authorisation Holder (MAH) has ultimate responsibility for every aspect of a licenced medicinal product including activities carried out by third parties.

If you are not directly in control of all activities it is imperative to be sure what is happening both before the registration process begins and during the marketing of your products, by way of audits.

Before purchasing a dossier/MA or signing up for a manufacturing contract, it is vital to carry our Due Diligence to avoid problems later on. Also the registration process can be shortened by submitting the most complete dossier possible

CambReg’s Gap Analysis Service

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

Clinical Trial Applications

CambReg will review and comment on your CTA submission package with a view to making it a ‘right first time’ application. We will look for common errors and rectify them in advance to avoid any validation errors. What we look out for in a Clinical Trial Application:

• Inclusion of any scientific advice summary received prior to the application
• Inclusion of any opinions or outcomes of paediatric investigation plan (PIPs) from EMA or paediatric committee (PDCO)
• That IMP labelling is acceptable and in correct format
• Absence of potential shortcomings in IMP supply chain with regards to -
  • Valid MIA/manufacturing authorisation
  • Compliance with GMP
  • Import from outside of the European Union
  • QP declaration
• Core documents such as IB, IMPD and application form are in correct pdf or xml format with regards to ‘content validation.’

Marketing Authorisation Dossiers - Review of a new data set or an existing MA

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

• Is it complete!
• Does it comply with current UK/EU guidelines?
• Are there any formatting issues/ is it in eCTD
• If it’s a live MA -
  • Is there a consistent record of what has been submitted to Health Authorities and actually what’s in the dossier?
  • Are there any on-going regulatory issues/pending variations?
  • Are there any new regulatory actions required
  • Are there any outstanding regulatory commitments (e.g. stability data)
  • Is the Product Information compliant
• If it’s an old or dormant MA is the information still relevant eg is the registered manufacturer still able and willing to carry out the manufacture

Results of Due Diligence activities can be presented in any report format that the client wishes.

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.

Audits or mock-inspections

We can organise any of the following

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

We have a knowledgeable core team as well as an international network of experienced regulatory associates who can advise on Due Diligence matters worldwide

For more information or an estimate, contact us »