SEQ are experts in pharmaceutical advice, regulatory strategy and regulatory affairs and is an established recognised service provider operating for close to 30 years. The individual letters S, E and Q stand for Safety, Efficacy and Quality, and it would be fair to say that chief executive and founder Mary Purcell knows what she is talking about. She is pharmacist by qualification who competed for Ireland in the Olympics of 1972 and 1976, and worked for the Irish Medicines Board. Shortly after her second Olympic appearance, her first daughter was born.
With juggling training for track and marathon, work and raising a family, she raised the game instead of quitting. She started her own company. It did not mean less work, but it meant smarter work and potentially higher rewards.
In the 1980s, as in every field, pharmaceutical regulatory affairs looked very different. Files were of course physical instead of digital, so each company’s dossier was housed in up to 20 lever arch files. Whenever a registration was made pan Europe, the dossier would typically be sent to 10-16 different countries, and each country required at a minimum three copies and in some cases 15 copies. That meant that for every job, up to 600 lever arch files needed photocopying and posting.
Thankfully multiple photocopying machines and packing boxes are no longer replaced by fully integrated electronic systems. Says middle child Jan Lewis: “We learned a lot! Time management, for one. And that if you want something, you’ll have to work for it.”
Jan Lewis is now SEQ’s business development manager, and her older sister, Dr Kara Purcell, is head of medical resources. Mary Purcell, now in her 60s, is still going strong as CEO. This year she ran the London Marathon together with Jan.
SEQ has a staff of 15 in Douglas, and five in Ireland. In addition to the Purcell family heading up the Medical Resources and Business Development parts of the operation, Dr Jayne Leslie is head of Regulatory Affairs.
With the EU introducing new/complicated regulation requirements throughout the 1990s and 2000s, SEQ’s expertise has been a welcome support to their European clients. They have achieved more than 500 new product approvals across Europe.
SEQ continues to apply its expertise worldwide in the pharmaceutical, device, herbal, food and cosmetic industries, project managing helping clients take their products from the initial development and licensing stage through manufacture, business development, quality auditing to market.
Projects are tailored to the needs of each individual client and can involve anything from complex strategy development, application project management involving the 28 EU member states, intricate expert medical opinions/defence positions, nonclinical and clinical summaries to readability user testing of patient information leaflets, to training staff strategies. SEQ also has access to a growing innovative and generic product portfolios.
Mary Purcell BSc(Pharm) MPSI is also a Fellow of TOPRA (The Organisation for Professionals in Regulatory Affairs).
Tel: +44 (0)1624 692999