ESPL Regulatory Consulting

Life Cycle Support

For many clients maintaining a regulatory approval is every bit as challenging as getting the approval in the first place.  We can provide services to maintain / vary your licences, to manage Sunset Clause submissions, and to extend your regulatory licences into new markets.

 

We all know that regulatory activities don’t just stop when the MAA / NDA is granted.  Within the EEA more than 60% of the regulatory agency workload relates to post-approval management of CTAs and MAAs!


Wide-Ranging Experience

The ESPL team has decades of experience with managing post-licensing activities. 
Here are some of the activities we can support:

  • Licence variations
  • 5-yearly renewals
  • MAA line extensions and supplemental NDAs
  • “Switch” applications (Rx to OTC changes)
  • Manufacturing Authorisation changes and updates
  • Notified Body audits.

We have supported all sorts of products, including borderlines, OTC and drug-devices, and can help your team in navigating the requirements to efficiently manage post licence changes.


For more information on how ESPL can support your business, contact us via the form below, and we can arrange a consultation.

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