Embedded Signal Processing Ltd (ESPL) was originally established in 1996 as an electronics development and consultancy company. In 2000 the business branched out and ESPL Regulatory Consulting was founded, led by Helen Erwood a former senior Regulatory Affairs Professional at SmithKline Beecham (now GlaxoSmithKline). ESPL has its main offices at Lunna House in the beautiful north-eastern corner of the mainland island of Shetland, with a second office in Glasgow and an array of remote staff across the UK and Europe. the company is today both a Shetland-based enterprise and a “virtual” business with staff and expert consultants based across Europe, North America and Australia.
ESPL values the integrity, professionalism and commitment of every member of its team; we believe that working to live, rather than living to work, is an important principle, and having a team with a healthy work-life balance and an enthusiasm for the task ahead means that the quality of support given to our clients is consistently high.
- Team members are task orientated: we don't have fixed office hours and work in complete tandem with family life.
- Our collaborative approach to managing the business means that we all care about supporting your regulatory needs.
- The team has a wealth of regulatory experience which means that we can engage with organisations and regulatory agencies at all levels.
The ESPL Team
Each member of the ESPL team brings enthusiasm for and specific experience in a wide range of aspects of regulatory affairs, so that we can provide just the right level of expertise and support our clients' need. Most of our team has a minium of ten years Regulatory Affairs experience in the pharmaceutical or devices industry (many have much more than this). Clients with complex submissions are supported by a multidisciplinary team, including an electronic publishing team, chosen to provide optimal support at each phase of any regulatory procedure.
Dr Helen Erwood
Helen has been working in Regulatory Affairs for nearly 30 years, following an initial stint as a research scientist with ICI. She has been a consultant since 2000.
Prior to consulting, Helen gained a broad experience in Regulatory Affairs within the Pharmaceutical, initially working for ICI Pharmaceuticals (now Astra-Zeneca) where she worked in anti-infectives, antiseptics and new pulmonary drug developments. She was responsible for forming the Regulatory Compliance team in the RA function and from there moved to Fisons in 1993 where she led a Regulatory Compliance Team through the aftermath of the FDA debacle in the early 1990s. In 1995 she became Associate Director of Compliance and Regulatory Affairs following the takeover of the company by Rhone Poulenc Rorer (now Sanofi Aventis).
In 1996 Helen moved to work in SmithKline Beecham Consumer Healthcare, (now GSK Consumer), where she was Director of Regulatory Affairs for the global oral health and gastrointestinal product portfolios.
In 2000 Helen moved on to work independently within the industry and started ESPL Regulatory Consulting. Helen therefore has a broad experience in regulatory affairs and compliance, including product developments in NCEs, the consumer sector, medical devices and borderline drug/device combinations as well as radiopharmaceuticals. When she is not working with the team to support new submissions, Helen regularly lectures on CTD (especially Module 3) requirements , EU and US procedures and Strategy; both in-house for companies and for external organisations, such as TOPRA.
Helen is CEO of the Irish company and a Director of the Swiss company.
Helen lists her most useful assets as her continuing enthusiasm for regulatory affairs and her infectious sense of humour. In her spare time Helen tends a small flock of sheep, renovates and decorates Lunna House, and bakes/cooks and then tries to find time for a little bit of gardening.
Tony has been a working Director of ESPL since its inception as an electronics company in 1996.
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, Seimens and V-Tech and developing embedded signal software applications for other clients.
Since the establishment of ESPL Regulatory Consulting in 2000, Tony’s role has developed and broadened such that he is the IT expert supporting the ESPL Regulatory Team, developing and optimising the network systems, supporting publishing for NeeS and eCTD submissions, as well as providing electronics expertise for medical device developments for clients.
Tony is CEO of the Swiss company and a Director of the Irish company.
When times permits Tony is a ham radio enthusiast (call sign: G7AFE) and also spends much of his spare time coordinating and engineering the major structural renovations that have been needed to Lunna House.
He is also a member of the Shetland Bus Friendship Society and liaises regularly with government and other groups in Norway to maintain and promote the wartime history of Lunna House and its links with the former resistance movement.
Jason joined the ESPL team as Associate Director of Regulatory Affairs in June 2017, bringing over 17 years of experience in Regulatory Affairs from both industry and consultancy.
Prior to joining the ESPL team, Jason was a consultant at RRG in Camberley, UK. In this role he provided support to clients across a variety of regulatory activities involving both medicines and medical devices, including clinical development, scientific advice (EMA, FDA and EU national) and Regulatory Agency negotiation right the way through to product authorisation and life cycle management, including preparation of relevant documents (eg. Module 3, IMPDs, IBs, SA Briefing documents, etc.). He was also responsible for the Quality Management System, including reviewing, updating, maintaining and training staff on the quality procedures, and managing external contractors, and brings some experience in supporting business development activities.
After degree and postgraduate studies, he began his regulatory career at Stiefel Laboratories in 1999, servicing the export markets (Ireland, Eastern Europe, Middle East and Africa). In 2004 he moved to Allergy Therapeutics as Regulatory Affairs Officer, later becoming Regulatory Affairs Manager, responsible for all regulatory affairs activities including new product development, life cycle management and regulatory operations across the company.
Jason is a former international hockey player, having gained over 50 caps, and is currently still playing and coaching. He is keen on many other sports, but spends most of his time either coaching or with his family and their sporting activities.
Dr Stefania Magenes
Stefania is a PhD Biochemist and has been a member of the ESPL team since 2011. Prior to joining the team Stefania spent more than 20 years in industry in various roles in Regulatory Affairs, Quality Assurance and R&D.
Immediately prior to joining ESPL, Stefania was responsible for the Anaesthetics Portfolio for Baxter Healthcare and coordinated numerous Decentralised and Mutual Recognition procedures, as well as overseeing the lifecycles of anaesthetic and related products. Stefania continues to provide expert support to clients on Module 3 (Quality) regulatory requirements for sterile products (intravenous solution and solutions for peritoneal dialysis and other forms such as tablets and creams).
Stefania also supports directing, managing and coordinating European MA submissions, via National, Decentralised and Mutual Recognition procedures. Some of the activities she undertakes are:
- Development of the most appropriate regulatory strategies for registering/introducing into the European market generics
- Planning the content, requirements and timelines for Marketing Authorization Applications (MAA)
- Establishing and managing the regulatory and scientific interface with strategic partners such as external expertise involved in marketing authorisations achievement, drug substance suppliers, drug product manufacturers
- Preparation of application files for marketing authorisations, variations and renewals
- Preparation of QOS and responses to the outstanding issues
- Contacts with the European Health Authorities
- Submission of the MAA / variations to the Italian authorities (AIFA)
In her spare time Stefania enjoys spending time with her husband and daughter in the mountains near Milan and supporting her young daughter with her championship swimming activities.
Dr Dolores Edmont
Dolores has a Ph. D. in Medicinal Chemistry (1999), and has worked in research for 8 years, focussing on diabetes, breast cancer, HIV and HBV. She is also a post-gradute in International Regulatory Affairs. She has been working in Regulatory Affairs for 5 years. She enjoys working with RA strategy and all steps before the MA application.
Dolores has worked in the past for Amatsi, which produce clinical trial batches, and Bausch & Lomb.
Dolores has worked for ESPL since 2011 and provides a broad range of consulting support for various submissions including:
- STED filings for medical devices
- ASEAN CTD dossier
- EU MA filing
- Regulatory strategy
Her pastimes and hobbies include basketball, country line dancing, horses, cooking and spending time with her family. She has a cat named Carmello, and a rabbit named Nougat
Beth has over 25 years experience working in pharmaceutical regulatory affairs. She has expertise from senior operational and strategic roles in the prescription, OTC and cosmetic sectors in Europe, the UK and Australia.
Beth started out in Melbourne Australia, where she became Head of RA for Smithkline Beecham ANZ. In 1999 she moved to London where she worked in both the OTC and cosmetic areas for GlaxoSmithline. In 2003 she moved to GE Healthcare where she was responsible for local market regulatory activities in Europe and International. Beth moved back to Melbourne in 2008 to look after the global influenza vaccine and Australian pharmaceutical regulatory activities for CSL Limited. In 2015 Beth left CSL and now works as a consultant based in Melbourne.
In her spare time, she runs a local cat rescue group involved in rehabilitation and rehoming of lost and stray cats.
Diane has a degree in Chemistry and also in Computing and IT. It was with great pleasure that she found a way to dovetail both of these by working for ESPL. She had worked adhoc with the company for a number of years before joining offically at the start of 2013.
She takes a major role in the publishing team. She prepares the pdf's, formats documents, tracks projects and compiles Nees and eCTD structures and submissions. She is involved with a number of aspects of module 1 administrative documentation. Diane also created and looks after the website and helps with project management.
Diane likes challenges and keeps very busy. In her spare time she is member of the volunteer Shetland Folk Festival committee,which is internationally renowned. She works all this around her family, who she is devoted to and she still makes time to ensure they all have a lot of fun.
Chris has been a working director of ESPL since 2010.
Chris qualified as an aeronautical engineer in 2013 and joined the business full time that year. He has an interest in materials sciences and supports the financial, IT and medical devices sectors of the business. Chris manages and is based at the Glasgow office. Chris is also a director of the Swiss and Irish sister companies.
In his spare time, Chris is an experienced skydiver and speedflyer (flying down mountains with a small parachute).
Alicia McDowall is Senior Projects Administrator, Alicia has a degree in Earth Sciences and is now a qualified Marine Mammal Medical trained in rescuing marine mammals.
Alicia is based in the Glasgow office and when she is not busy supporting the team, she loves animals and wildlife in general.