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.
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.
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.
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.
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.