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.
Chris is Finance and IT Director at ESPL and has been a director since 2011. In his role he manages the infrastructure needed to support the international regulatory team. Chris manages the Glasgow office and supports the medical device section of the business, with experience in QMS development and regulatory strategy.
Tony was a founding Director of ESPL. Following an academic career at Loughborough University and then at Manchester University, in electronics and electrical engineering, Tony moved over to working independently, initially contracting to major electronics companies such as Philips, Siemens and V-Tech and developing embedded signal software applications for other clients. Tony is Chairman of Employee Ownership Trust, a member …
Helen has 30 years of Regulatory Affairs experience and founded ESPL in 2000. Before making the move into consulting, Helen gained experience working with ICI Pharmaceuticals (now Astro-Zeneca), Fisons and SmithKline Beecham (now GlaxoSmithKline). Helen has a broad experience in regulatory affairs and compliance, including product developments in NCE’s, the consumer sector, medical devices and borderline drug/device combinations as well as radiopharmaceuticals.
Jason is ESPL’s Managing Director and has over 20 years of experience in Regulatory Affairs in both industry and consultancy roles. After his postgraduate studies he began his regulatory career at Stiefel Laboratories in 1999, before moving to Allergy Therapeutics, where he progressed to managing the global regulatory affairs function. In 2011 he moved into consultancy, initially with RRG, and then joining ESPL in 2017. Jason has worked on a broad range of projects, including biologicals, particularly supporting pre-MAA activities. Jason has also gained Chartered Scientist recognition in Regulatory Affairs through TOPRA
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