Our specialist team is experienced in regulatory affairs, product development, quality assurance, drug safety, medical information, copy approval, project management, training and market access.
We can provide support at all levels, from strategy through to administration, which allows us to tailor our services to meet your specific needs as your company moves from innovation and development to the market place.
JensonR+ was formed in 2011, through a joint venture with the regulatory consultancy, Dr Regenold GmbH. Our clients range from small innovators and entrepreneurs, through to Blue Chip corporations, and come from the human and veterinary pharmaceutical, cosmetics, foods, devices, herbals and legal industries.
After the referendum which resulted in the decision for the UK to leave the European Union, and with UK exit negotiations underway, it became apparent that there was a large degree of uncertainty of what the post Brexit landscape would look like. JensonR+ prides itself on being a professional and adaptable organisation, this ensures we deliver consistently high levels of service, support and successes. As part of our continuing commitment to all our clients, existing and new, in 2017 we announced the formation of JensonR+ (Ireland) Ltd – our Ireland based office – to ensure we can continue to provide our clients with our full service offering. We believe that this proactive attitude to Brexit will help protect your brands, equity and help you build strategic blueprints.
Meet our team
Chief Executive Officer
Sarah Ware BSc (Hons); MTOPRA
Sarah is a pharmaceutical industry professional with more than 25 years of experience. After graduating from Exeter University with a degree in Biological and Medicinal Chemistry, Sarah joined GSK as a medicinal chemist. At GSK, she gained experience in drug discovery, development and project planning before moving into regulatory affairs in 2002.
Sarah joined the regulatory team at JensonR+ Ltd in 2010 and during this time has successfully delivered many regulatory projects and procedures.
Sarah became Chief Executive Officer in 2015 but remains involved in a wide portfolio of projects and enjoys guiding clients through the regulatory minefield.
Sarah has two teenage children. She enjoys running in her spare time and is extending that to duathlons.
Nicola Hardman BSc (Hons); MRSB; Pg Dip Reg Affs; Dip Pharm Ethics; FTOPRA
Nicola is a pharmaceutical industry professional with more than 20 years of experience in ethical pharmaceuticals.
She is a fellow of TOPRA, a qualified pharmaceutical ethicist and a BARQA trained lead auditor.
Nicola is currently an MHRA-registered responsible person. She is also a registered reviewer for medicines promotional copy with MHRA, ABPI (PMCPA) and PAGB.
She is a company director for the technical consultancy businesses, JensonR+ Ltd and JensonR+ (Ireland) Ltd.
Prior to becoming a consultant, Nicola gained extensive experience in the fields of regulatory affairs, quality assurance and market access.
In her day-to-day role, Nicola provides RP oversight, auditing, advice and training on medicines supply chains, designs and builds GDP and GMP quality systems, conducts due diligence and gap analysis exercises, provides strategic and market access advice, and medical/technical writing support.
James Hall BSc (Hons); FTOPRA
James joined JensonR+ Ltd in 2012 and has over 25 years’ regulatory experience predominantly in the OTC sector of the industry.
His background covers a wide spectrum of areas including regulatory strategy and implementation, borderline products, promotional copy approval, reclassifications, medical devices and pharmacovigilance. James has worked with several major pharmaceutical companies and a wide scope of entrepreneurial clients. He is a board member within JensonR+ Ltd.
James has a degree in Applied Biology and is a fellow of TOPRA.
His role within Jenson covers business development, regulatory strategy and implementation for clients, promotional copy review and regulatory team management.
QPPV & Pharmacovigilance Manager
Sue is a pharmaceutical industry professional with over 20 years’ experience.
Sue has been with Jenson R+ Ltd for 6 years and EU QPPV for the past 5 years.
In her day-to-day role, Sue is also the PV team manager, the HR lead and supports the integrated quality management team.
Sue’s career has evolved through nursing and nurse teaching; she has experience in medical sales, and clinical trials and drug safety in some of the larger pharma companies.
Sue enjoys bringing elements of health and wellbeing to the company values. Out of the office, Sue enjoys trekking challenges, yoga and family time.
Lisa Courtier Cert Health Sci; MPIPA
Lisa is a pharmaceutical industry professional with more than 9 years of experience in drug safety and pharmacovigilance roles and is a member of PIPA.
In 2010, she joined Celgene Ltd as a drug safety administrator, progressing to drug safety associate and eventually to specialist. She moved to North Devon in 2015 and joined JensonR+ Ltd as a drug safety officer.
Lisa is responsible for the handling and processing of safety information including ADRs and ISCRs, performing suitable follow-up activities with reporters, conducting literature reviews of published data, collecting information in relation to our partner SDEAs, signal management activities, PSMF updates and managing partner meetings.
She has a young daughter and enjoys outdoor activities such as camping, spending time at the beach and some occasional running.
David Lough BSc. (Hons); MSc; APIPA
David is in his 3rd year as a pharmacovigilance professional with Jenson R+ Ltd – his first role in the industry. David graduated from the University of Glasgow with a degree in Physics before completing his master’s in Biomedical Engineering at the University of Strathclyde.
In his day-to-day role, David is responsible for the handling and processing of safety information including ADRs and ICSRs, conducting literature reviews of published data and works closely with the deputy QPPV on the xEVMPD system.
In addition to this David works on Jenson R+ Ltd’s medical device vigilance system and acts as an administrator for the global safety database.
David plays for his local football team, Fremington FC and is a keen golfer.
Mandy is a qualified RGN with over 20 years’ nursing experience including working on clinical trials, oncology, gastroenterology, prostate cancer and hepatitis C.
She joined the team at JensonR+ Ltd in 2018 working across both PV and MI services, initially as medical information scientist and pharmacovigilance officer. She has now taken on the role of scientific manager, continuing to develop and expand the MI service. Her role also includes RMP-writing and signal management and and she continues to work across both MI and pharmacovigilance, applying her wide ranging clinical knowledge base to both areas.
Mandy has two teenage children and enjoys a variety of exercise which is handy when she is married to a personal trainer. She regularly participates in both ballroom and latin dancing and has recently started to practice yoga. Other interests include walking, cooking, baking and musicals.
Medical Information Officer
Marilyn Brown MPIPA
Marilyn is a pharmaceutical industry professional having over 19 years of experience in ethical pharmaceuticals with major pharmaceutical companies and the NHS. She joined Jenson R+ Ltd in 2004 and is the first point of contact for medical information, patients and industry as well as regulatory and quality enquiries when required. In addition, Marilyn collates and writes detailed responses to enquiries raised by healthcare professionals.
Marilyn is a member of PIPA (Pharmaceutical Information & Pharmacovigilance Association) and is a registered reviewer for medicines promotional copy with MHRA and ABPI (PMCPA).
Prior to becoming a consultant, Marilyn was employed at the School of Biological Sciences, Royal Holloway University of London.
Marilyn lives in North Devon and enjoys art, crafts and pottery.
Neil Prideaux BSc; MTOPRA
Neil and his team are involved with the preparation and submission of marketing authorisation applications along with their maintenance post approval. He oversees the regulatory management system, which is used for the managing and generation of eCTD submissions.
Neil joined JensonR+ Ltd in 2012 after gaining a PGCE from the University of Exeter. He previously studied part time to obtain an HNC in Applied Science followed by a BSc from the Open University. He became regulatory manager in 2017.
Due to his previous experience working in regulatory for a contract manufacturer of cosmetics, he can provide regulatory advice to clients considering marketing cosmetics in the EU. Before working in regulatory he worked in retail and as an assistant analyst for a medicines manufacturer.
Neil has two school-age daughters.
Regulatory Officer and Responsible Person
Chloe Child MChem, AMRSC, MTOPRA
Chloe joined JensonR+ Ltd as a graduate in 2016, after gaining a first-class Master of Chemistry (MChem) degree with Honours in Chemical Biology from the University of Warwick. Within the company, Chloe works cross functionally as part of both the regulatory and quality departments.
Chloe is currently an MHRA-registered responsible person (RP).
As part of the regulatory team, Chloe is involved in the preparation of marketing authorisation applications, building eCTD submissions and publishing. Alongside this, other regulatory activities include due diligence and the submission and maintenance of WDA licences via the MHRA portal.
Chloe provides RP oversight, auditing, support with the set up and maintenance of quality management systems and designs supply flows for human medicines in both ambient and cold chain conditions.
In her spare time Chloe enjoys keeping active and exploring the Devon coastline.
Kathryn Vale BSc (Hons)
Kathryn joined JensonR+ Ltd as a regulatory officer in August 2019 with more than 12 years of regulatory experience within the pharmaceutical industry. She graduated from the University of the West of England in 2007, with a BSc (Hons) degree in Biomedical Science. She has since achieved the TOPRA Postgraduate Certificate in Regulatory Affairs from the University of Wales.
During her career she has gained experience in many aspects of regulatory and medical affairs including marketing authorisation maintenance, safety variations and renewals, maintenance of food supplements and cosmetics, change of ownership applications and medical information service provision. Kathryn also has experience of compiling eCTD sequences and the submission of applications using CESP and the MHRA portal.
Kathryn enjoys running in her spare time and hopes to complete her first marathon in 2020.
Janet joined Jenson R+ Ltd in April 2019, as regulatory affairs manager based in the Nottingham office. This followed running her own consultancy business, consult2deliver limited, based in BioCity Nottingham. She began crafting her regulatory skills at Thomas Kerfoot and Medeva in Ashton under Lyne, before moving to 3M as the global regulatory lead for Qvar, the first CFC-free beclomethasone inhaler.
Her first role in OTC medicines began at Boots the Chemist, gaining approval of new consumer medicines for the new Republic of Ireland stores, before transferring to senior roles within Boots Healthcare International, supporting Strepsils globally.
Operational roles combined with global regulatory responsibilities saw a return to dry powder inhaled drug development with Vectura. Latterly at Boots Pharmaceuticals she was the head of innovative regulatory affairs, assessing solutions for consumers in healthcare, covering medical devices, food supplements through to reclassification strategies.
Senior Regulatory Officer
Sue Lakeman BSc (Hons), MTOPRA
Sue is a pharmaceutical industry professional with more than 20 years of international regulatory affairs experience. Prior to this Sue worked for 10 years as a formulation scientist, providing in depth technical background to support her regulatory expertise.
Sue joined Jenson R+ Ltd in 2013, prior to which she gained extensive regulatory affairs experience within large multinational organisations, including EU, US and national procedures over a broad range of OTC and prescription pharmaceutical products.
In her day-to-day role, Sue provides strategic advice to clients, through all stages of product development and post-approval. Sue has a particular expertise in procedure management and technical writing support.
In her spare time, Sue is a keen wildlife enthusiast, with a special interest in whale and dolphin conservation.
Senior Regulatory Officer
Joanne Lokes MTOPRA
Joanne is a pharmaceutical industry professional with over 25 years of experience in the registration of medicines in the UK and Europe, across different therapeutic areas and legal categories.
Joanne joined the regulatory team at JensonR+ Ltd in 2012 and during this time has been involved in many different types of projects and procedures.
In her day-to-day role, Joanne provides strategic advice, dossier preparation and submission of documents to authorities. Joanne’s area of expertise is in post authorisation regulatory activities.
Joanne is a registered reviewer for medicines promotional copy with MHRA, ABPI (PMCPA) and PAGB.
She is also a member of TOPRA.
Senior Regulatory Officer
Melanie Joy BSc (Hons), MRSC CChem. MTOPRA
Melanie is a pharmaceutical industry professional with more than 24 years of international regulatory affairs experience in OTC and prescription pharmaceuticals.
Prior to becoming a consultant, Melanie gained extensive experience within large multinational organisations, small development companies and clinical trials organisations preparing submissions to support initial and post-marketing applications in the EU, US and other global territories.
Melanie worked as an analyst prior to entering the field of regulatory affairs.
Melanie currently prepares dossier modules, manages submission procedures and coordinates preparation of scientific advice packages for clients.
Ben Smith MChem (Hons)
Ben’s career in the pharmaceutical industry started in 2014 in the quality assurance field. In this position he supported a major blue-chip company in the manufacturing activities of a prescription medicine sold in over 100 markets worldwide. In 2016 his role transitioned into regulatory affairs, where he supported license variations, renewals and applications into new markets.
In 2017 he joined the regulatory affairs team of a clinical trials organisation. In this role he prepared the quality IMPD modules and assisted in study specific CMC strategy for a wide range of clients, from university spin-offs to international corporations.
Ben joined JensonR+ Ltd in October 2019 as regulatory officer, looking to support our clients with a wide range of regulatory activities from eCTD dossier creation to advice on borderline medicines.
Ben graduated from Loughborough University in 2013 with a Master of Chemistry (MChem) degree with Honours in Medicinal and Pharmaceutical Chemistry. In his spare time, he likes to climb, run and play cricket.
Qualified Person for Pharmacovigilance
Sarah Pender BSc (Hons); MSc
Sarah has over 14 years of pharmacovigilance experience. Having graduated from UCD with an honour’s degree in Physiology in 2005, Sarah started her career in pharmacovigilance and has worked for a number of pharmaceutical companies in the clinical and post-marketing setting. She has also returned to college and completed her master’s degree in Pharmaceutical Medicine and her diploma in Project Management.
Sarah has experience in a wide range of pharmacovigilance activities. Prior to joining JensonR+ (Ireland) Ltd, Sarah was responsible for managing pharmacovigilance related projects including large-scale global acquisitions.
Sarah joined the team at JensonR+ Ireland in January 2019, as EU QPPV. Since then, she has been involved in the set-up of the Irish office and PV systems.
Paul is a qualified person with over 18 years of experience in the pharmaceutical industry. Paul graduated from Dublin City University with a degree in Chemical and Pharmaceutical Science in 2001. He has held a number of laboratory-based roles with Athlone Laboratories, Pfizer and Allergan before moving into quality assurance in 2009.
Having held management positions in quality assurance and quality systems, Paul went on to complete the MSc in Pharmaceutical Technology and Quality Systems in UCC graduating in 2016.
Paul joined JensonR+ (Ireland) Ltd in 2019 as a qualified person and has been heavily involved in the setup of the quality system at the Dublin office which has now been granted a Manufacturing and Importation Authorisation by the HPRA. Paul is responsible for batch release and associated activities.
Paul has three children and enjoys playing football in his spare time.
Rosaria Spina MSc.
Rosaria graduated with a master’s degree in Medicinal and Pharmaceutical Chemistry at the University of Naples Federico II.
Her career in pharma started in 2018 as pharmacovigilance quality management and compliance associate. This experience gave her a good understanding of GVP requirements and the quality management activities to ensure compliance with the regulations. Prior to this, she worked as a researcher involved in a nanomedicine project at University of Naples Federico II, and subsequently in an organic chemistry project at Royal College of Surgeons in Dublin.
Rosaria joined JensonR+ (Ireland) Ltd in September 2019 as scientific officer. She is involved in providing regulatory, pharmacovigilance and quality support services.
Responsible Person & Technical Manager
Matthew Burton MTOPRA, IRCA
Matt is a pharmaceutical industry professional with over 23 years of experience in the sector. Matt started out as an organic chemist at Tripos/Exelgen where he utilised robots to synthesize and purify drug-like compounds.
Matt joined the Jenson R+ Ltd team in 2010. His expertise covers development, manufacture, distribution, QA and regulatory affairs across multiple dosage forms, medical devices and borderline products.
He supports clients by providing technical oversight from concept right through to post-licensing. He offers training, project management, due diligence/gap analysis and audit services whilst also supporting the business development function of Jenson.
Matt is an MHRA-registered responsible person, a lead auditor (GxP) and a member of TOPRA.
A lifelong surfer, Matt has two young children and a passion for hardy tropical gardening.
Susan is a pharmaceutical industry professional who joined JensonR+ Ltd in 2012.
She administers, and provides project management of, the copy approval system for promotional materials; she can also provide regulatory review in line with the ABPI Code of Practice and the MHRA Blue Guide.
Susan enjoys managing the interface with clients and consultants, and also obtains export certificates, notarised documentation and consular legalisation. She has a legal and civil-service background, with 5 years working for DEFRA following time as a junior legal executive.
An awful lot of her spare time is spent writing fiction, pursuing publication and reviewing novels, which means editing and copy editing her own work. This love of written language spills over into her day job.
Lydia joined Jenson R+ Ltd at the beginning of 2018 and works cross-functionally supporting both the technical and quality departments.
As part of the technical team, Lydia coordinates market access for clients, proof reading and processing copy approval materials. She also assists with CMP/CPP applications when required.
Within the quality team Lydia manages the complaints process, alongside SOP system management and coordination, also ensuring documentation is filed appropriately and adheres to compliance requirements. Lydia has an understanding of GMP and GDP requirements and supports the RPs within Jenson R+ Ltd.
Lydia is a trained mental health first aider and the mental health champion at Jenson R+ Ltd. Before joining Jenson R Ltd, Lydia worked within programme coordination and student welfare/support. She has a first-class psychology degree.
Quality Assurance Manager
Rebecca Liversedge BSc (Joint Hons); MSc
Rebecca joined the company in 2015 and has over 19 years’ experience within the pharmaceutical industry working in generic medicines, traditional herbal medicines, veterinary pharmaceuticals, food supplements, pharmacovigilance, clinical trials monitoring and quality assurance. Rebecca has also received GDP Responsible Persons training.
Rebecca has previously worked extensively in UK based pharmaceutical manufacturing plants as a regulatory professional and has worked within several pharmaceutical consultancies. Rebecca also holds a Post Graduate Certificate in Education and uses this skill to deliver training. In the past, she has also been on the editorial team for the TOPRA publication.
As quality assurance manager for JensonR+ Ltd, Rebecca uses her experience and knowledge to support company and client quality–related activities and the running of quality management systems both for the company and its clients.
Rebecca is a keen rower of Cornish pilot gigs, a six-person crewed sea going rowing boat; as a member of her local club, she often competes in weekend rowing regattas held around the beautiful local coastlines of Devon and Cornwall.
Claire has a varied career background. She was born in North Devon and relocated to London in 1996, where she served as a metropolitan police officer for 12 years. Claire became a detective constable working in the homicide command, gaining experience in complex investigations, analysing data and detailed record keeping.
Following the birth of her daughter, Claire and her family relocated to Devon and she joined Accord Healthcare working in the quality assurance department. Claire’s skills were transferrable to the pharmaceutical industry and she gained a detailed knowledge of GMP and GDP working for this multi-national pharmaceutical company.
Claire joined JensonR+ Ltd in April 2019 as quality assurance officer and has endeavoured to promote a positive QA culture within the workplace and with client accounts.
Claire has one young daughter and enjoys running, cooking and spending time with her family.
Shane Sankey BSc (Hons); AAT
Shane is a part-qualified (AAT) accountant with more than 20 years of experience in an accounting environment.
He is currently finance manager for JensonR+ Ltd having joined the company in 2012. He previously spent nine years working for a leading IT services company, progressing rapidly from accounts assistant to accounts manager, a role he held for eight years.
Prior to gaining his AAT qualification, Shane achieved a 2:1 in his Environmental Sciences degree at the University of Greenwich.
Shane currently manages all areas of the accounts function for JensonR+ Ltd reporting in to the CEO, the Jenson R+ Ltd board and company accountants. His day-to-day role includes raising invoices to clients, processing supplier payments, bank reconciliation and production of monthly management accounts, statutory reports and company budgets.
Rebekah has had a varied and extensive working history in administration, including six years as PA to the sales and marketing director of a leading pharmaceutical manufacturer. Prior to joining Jenson R+ Ltd, her most recent role was administrative assistant to several Macmillan Cancer Support caseworkers. The project’s aim was to assist people with cancer or a ‘life limiting’ condition to claim any eligible welfare benefit entitlement. She liaised with healthcare professionals to ensure they were getting all the support they required.
Rebekah joined Jenson R+Ltd in 2014 as administration officer, barely getting a foot in the door before adapting her role to provide support to the QPPV and pharmacovigilance team. Due to the growth of Jenson R+ Ltd, Rebekah moved across to the finance department as finance assistant, in order to support the finance manager in providing a complete finance service to the whole of the company; addressing all issues of a finance nature and providing all relevant information to meet internal and external demands.
Jo is AAT qualified and has experience of working in admin and finance roles in both accounting practices and the pharmaceutical industry. Prior to joining JensonR+ Ltd, Jo spent 7 years working as a finance officer for Perrigo.
In 2015, Jo joined the operations team at JensonR+ Ltd as an administrative officer.
In her day-to-day role, Jo is responsible for providing administrative support to all teams within the company, including co-ordination of travel for staff, maintaining service provider contracts, business co-ordination and administration and she also provides support to the finance team and HR lead.
Jo has two teenage children and in her spare time she enjoys running and going to the gym.
Jo is an administrative officer and joined JensonR+ Ltd in 2019 having previously worked for 8 years as a secretary for one of the conveyancing partners at a local firm of solicitors.
In her day-to-day role, Jo is responsible for providing administrative support to all departments within JensonR+ Ltd. This includes providing travel co-ordination for staff, reception duties including greeting clients on the phone and liaising with outside organisations to ensure the smooth running of the business.
Jo has two teenage daughters, one of whom is currently studying at university. In her spare time Jo enjoys running with the Fremington Trailblazers and socialising with friends.
Responsible Person & Technical Manager
Anthony Chapman BSc (Hons); MSc; MRSB
Anthony is a pharmaceutical industry professional with 21 years of experience. Having graduated from the University of Sheffield with a degree in Genetics in 1993, Anthony joined Perrigo (formally Wrafton Laboratories) as a laboratory analyst. Whilst at Perrigo, he gained practical laboratory experience before moving into the development department as a development chemist, and then stability chemist, for generic and branded OTC drug products.
Anthony graduated from the University of Exeter with a master’s degree in Bioinformatics in 2005 and subsequently worked as a software programmer for a web-design company.
Anthony joined the regulatory and quality teams at JensonR+ Ltd in 2007 and during this time has been involved in many different types of regulatory, development, and quality projects.
Anthony became technical manager in 2009 and is currently the responsible person for several Jenson R+ Ltd clients.
QPPV & Senior Pharmacovigilance Officer
Helen is qualified to graduate level in Natural Sciences with Biology from the Open University. She has over 22 years’ experience of within the generics pharmaceutical industry, 15 of which have been with Jenson R+ Ltd.
She gained experience in drug regulatory and medical information with Cox Pharmaceuticals (now Accord) before moving to Jenson Pharmaceutical Services (now JensonR+ Ltd) in July 2004 as a regulatory and pharmacovigilance officer.
Helen is currently working as a senior pharmacovigilance officer with a particular responsibility as the company deputy qualified person for pharmacovigilance.
Helen has a young son and enjoys travelling in her spare time.
One of our Board members and an expert in business development, market access, portfolio-management, including due diligence and licensing, and product supply processes. Jutta is also the managing director of Dr. Regenold GmbH.
A practising physician with 20 plus years’ experience in medical and clinical functions, gained within diverse companies ranging from large multinationals to SMEs. Duncan has worked with people from a wide range of roles as well as with NICE, public health and policy advisory committees, and academia.
A pharmaceutical marketer in the UK and Ireland with over 25 years’ experience in all aspects of marketing, Linda supports JensonR+ Ltd with product launch plans, including pricing and reimbursement, and in promotional compliance.
Graham has a wealth of QA and QC experience gained across pharmaceuticals and medical devices. Graham currently assists JensonR+ Ltd providing support on clients QMS activities and training in QMS principles
JensonR+ Limited is a lead member of the international regulatory network regulanet®
regulanet® is a group of highly skilled, experienced, like minded individuals and their companies, who have come together to offer a complete healthcare development service. Together, we form a network with representation in over 90 countries throughout the world. The services we offer span all aspects of product development, from brand and company strategy, product formulation and development, packaging development and implementation, extensive clinical, medical and regulatory expertise coupled with technology sourcing, product licensing and world class project management capabilities.
Founded in 2001 by Dr. Regenold GmbH, regulanet® offers services to a wide variety of national and international healthcare and pharmaceutical clients. The members of the network provide advice and assistance on national and international projects and marketing authorisation procedures, including the decentralised, mutual recognition and centralised procedures within Europe.
Our clients can utilise all of the resources that regulanet® can offer, or just access a specific part of our capabilities. Whatever your requirements, a project leader will provide a single point of contact and coordinate all project activity across the network.
Over the years the services offered by members have been expanded and now include all aspects of development, regulatory and market access in their respective countries.