Leading pharmaceutical and biotech product development consultancy Boyds has added to its regulatory team with the appointments of Shalini Gupta and Sarah Stevenson in response to recent growth and the continued increase in demand for its dedicated regulatory services.

Shalini Gupta joins the company as Senior Manager, Regulatory Affairs, and brings over 10 years of industry experience in regulatory submissions across a wide range of biologics and pharmaceutical products including advanced cell and gene therapy products. Shalini has specific expertise in CMC and regulatory aspects of EU applications for clinical trials and marketing authorisations, and post-marketing procedures.

Sarah Stevenson has also joined as Regulatory, Scientific and Medical Writer. Sarah is a PhD qualified writer with over 16 years of medical writing experience, including authoring and co-authoring a range of regulatory documents across different therapeutic areas including neurology, oncology, rheumatology, and ophthalmology. Sarah is skilled in preparing clinical study protocols and amendments, clinical study reports, patient/subject narratives, investigator brochures, CTD modules, regulatory responses, briefing books, investigational medicinal product dossiers and pharmacy manuals.

Boyds recently embarked on a large recruitment drive to increase capacity, capabilities and expertise as the company continues to grow in the UK and Ireland as well as establishing a US office. Shalini and Sarah are the first in a number of appointments being made, and they will be joining the Cambridge office to support clients across the globe.

Dr Julie Warner, Vice President of Regulatory Affairs at Boyds, says: “We are delighted to welcome Shalini and Sarah to the team. We continue to see an increased demand from biotechs and academic groups looking for our regulatory expertise and support, particularly in advanced therapy medicinal products (ATMPs), and cell and gene therapies. Their expertise and skills will enhance our current offering, and Sarah will be our first in-house regulatory, scientific and medical writer, which will help us provide a seamless service to our clients.”