The medicine and healthcare industry has very specific requirements for presentation of documents, and we know how to ensure your submission is prepared to the highest quality.
We offer a full publishing service to support submissions in the EEA, UK and North America, including:
- Pre-publishing checks:
- Formatting and integrity checks of Microsoft Word modules.
- OCR (Optical Character Recognition). Checking of scanned reports / documents.
- Preparation of PDFs for publishing.
- Publishing of e-CTDs (electronic common technical document) sequences and construction of NeeS directories
- Upload / submission of applications via the various regulatory agency portals (including CESP, MHRA Portal, FDA ESG, EMA IRIS system).
“Being good at publishing means having a clear eye for the detail and a passion for the quality of the eCTD and STED files we give to the Regulatory Authorities.” Helen Erwood, Chairman
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.