Since 2000, ESPL has been supporting clients in developing, seeking authorisations for and maintaining authorisations for many different types of product. For a large proportion of our clients, we have helped define and refine regulatory strategies, and continued to work with them to bring the products to market in the most efficient way. Our team has supported applications in many parts of the world.
Your all-the-way advisor
At ESPL, we don’t just give you advice and leave you to progress on your own. We pride ourselves on being there throughout your project, supporting all the difference aspects of development and licensing, in order to bring your product to market. Many of our clients have worked with us for years, and are reassured that they can turn to us for support at any time during their project, knowing that the team has the history and understanding of their needs, and comfort that ESPL has experience and expertise to help, whatever the stage of development.
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, provide expert support and sign-off, and publish submissions. We can also act as an interim 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.
We provide expertise to our clients in the medical device industry by offering support regarding medical device clinical trial notifications, ISO 13485 certification, CE marking (including compiling technical files) and local notification procedures prior to marketing.
Our own in-house publishing team can publish and maintain your e-CTD for EU and US submission, including ASMFs/DMFs. 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 TOPRA “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.
Regulatory strategies and decisions need to be made with a clear rationale and purpose, and as we know, this can be a rapidly changing environment, and so previous precedents are not always relevant or reliable. Our view is that there should be a clear purpose and justification for any regulatory decisions, and this may mean treading new paths and finding novel approaches. Remember, guidelines are not god-lines, and if there is a good, scientifically sound justification for a particular action, then this just needs to be explained.
“Working with a diverse range of companies means every day is different, and challenges us to keep learning and applying creativity to our work.” Jason Collins, Managing Director