Whilst it may not be the most exciting, maintaining your authorisations is key to ensuring longevity and return, and ESPL can help you keep those authorisations neat and tidy.
The ESPL has decades of wide-ranging experience with managing post-license activities.
We can provide support with:
- Licence variations
- 5- yearly renewals
- MAA line extensions and supplemental NDAs
- “Switch” applications (Rx to OTC changes). This is an application which can be made when a product has been available as a prescription medicine for some time and the safety is well known. If the product is considered sufficiently safe it can switch to OTC (over the counter) status.
- Manufacturing Authorisation changes and updates.
- Notified Body audits.
The range of products we have supported includes borderlines, OTC and drug-devices. We have the experience to help your team in navigating the requirements to efficiently manage post licence changes.
“Lifecycle management is the key to keeping your products on the market, growing and profitable. It’s often not seen as the sexy end of Regulatory Affairs (even though it can be). It’s the key to compliance – and being compliant is the key to success!”
We provide flexible and comprehensive support for clinical trial, MAA and NDA submissions for both small molecule and biological products. We can prepare all relevant documents, review your documents, and publish submissions. We can also act as an MA Holder in the UK and EU.
ESPL has significant experience in supporting clients with local and global regulatory strategies, as well as preparing and coordinating advice from regulatory agencies for a wide range of different therapeutic areas with both SME’s and big Pharma. We also support clients with PRIME, PIP, Orphan, ATMP and drug-device applications.
Our own in-house publishing team can publish and maintain your e-CTD for EU and US submission, including ASMFs/DMFs and CEPs. The team can publish your documents, and submit them via CESP, MHRA Portal, FDA ESG, etc.
At ESPL we offer a comprehensive regulatory affairs training package. In 2012 the principal trainer, Helen Erwood, was nominated for the TORPA “inspiration” award, and several team members lead and present at TOPRA training courses.
Regulatory activities don’t just stop when the MAA/NDA is granted, which is why ESPL provides support for the full life cycle of your product. We can provide services to maintain/vary your licences, to manage Sunset Clause submissions, and to extend your regulatory licences into new markets.