Huddersfield-based Woodley BioReg launches an Italian subsidiary as part of its strategy for global expansion

Based in Milan, the office will open up new avenues and routes to market for clients using its consulting and import services.

The Huddersfield-based company said the move will significantly enhance the level of services Woodley BioReg can offer its non-EU clients, particularly those based in South Asia and Asia-Pacific regions.

In a statement, the company said: “The decision to open a legal entity and new office in Italy has come about due to the impact of Brexit, with a number of EC directives requiring a European base for bringing products to the European market, something that Woodley BioReg could no longer provide directly to clients in the wake of the UK’s exit from the EU, instead relying on European partners.

“The decision to base the subsidiary in Italy over other member states is due to the country being a founding member state of the union and as such the regulatory body, the Italian Medicines Agency (AIFA), is well established and extremely active in European regulatory affairs.”

AIFA continues to be a key contributor to the European Medicine Agency (EMA) and Woodley BioReg said it has had a number of positive interactions with the Italian regulatory agency in relation to legislation for both pharmaceutical and biopharmaceutical products.

Dr Ash Ramzan, managing director and principal regulatory consultant at Woodley BioReg, commented: “We want to provide a seamless experience for our clients looking to bring their products to the European market, and therefore it’s imperative that we have our own base in the EU to facilitate that.

“We’re extremely excited to begin operations in Italy – which will start with immediate effect – and have the utmost respect for those operating in the healthcare industry there.

“We’re particularly looking forward to working more closely with the experts at AIFA, as their reputation precedes them.”

The office will be manned by a mix of local professionals and visiting consultants and support staff from the UK headquarters.

The statement added: “The move is in line with Woodley BioReg’s ambitious growth plans which has seen the business make four key hires in the last six months. Although already operating on a global scale, the firm is looking to expand in targeted sectors and markets to drive forward on its objectives for the financial year.”

Dr Ramzan has more than 25 years’ experience in the biopharmaceutical and pharmaceutical industry and Woodley BioReg is involved in a diverse range of projects which reflect our changing times.

For example, in 2020, it helped a manufacturer in Anglesey transform its business from a completely unrelated product to producing PPE.

Woodley BioReg aims to create an environment which is built around solving complex pharmaceutical development and registration problems, according to Dr Ramzan.

He told The Yorkshire Post recently: “It’s very easy to grow the business but the key issue is maintaining quality; after 20 years we don’t want to start cutting corners.

“A lot of the growth has been through our networks and word of mouth.

“Covid-19 has been a wake-up call. I hope it is a wake-up call to invest in scientific infrastructure in the UK.

“There are scientific experts but they are almost invisible and end up as the poor cousins in terms of funding and support. Hopefully, recognition of the value of science in tackling the pandemic will lead to more investment in infrastructure.”

Dr Ramzan also believes action is required to address the needs of an older population, by securing medicines from lower cost centres around the world.

Woodley BioReg helps pharmaceutical, biopharmaceutical, healthcare, and medical device companies develop and manufacture products that are effective and safe for patients worldwide.

Operating for more than 20 years, and with offices in China, South Korea, Poland, and Italy – as well as headquarters in Huddersfield, Yorkshire – WBR provides scientific advice and consulting services in regulatory affairs, and project management for all stages of product development.

Yorkshire-based Woodley BioReg acts as the link between the global boards of health, regulatory agencies, and healthcare product manufacturers.