Regulatory affairs consultancy expands into Europe with launch of Italian subsidiary and office

• Forms Italian business entity Woodley BioReg Srl
• Opens office in Milan
• Aims to provide seamless experience to clients entering the EU market

Drug and medical device regulatory affairs consultancy, Woodley BioReg, is celebrating the launch of its new Italian subsidiary, Woodley BioReg Srl, as of 1^st April 2022.

Based in the northern Italian city of Milan, this office will serve to fortify Woodley BioReg’s access to the European market, opening up new avenues and routes to market for clients using its consulting and import services.  This 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.

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 2001/83 Directives (including for example Art 98) 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 has had a number of positive interactions with the Italian regulatory agency in relation to legislation for both pharmaceutical and biopharmaceutical products.

Managing director and principal regulatory consultant at Woodley BioReg, Dr. Ash Ramzan, 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 — promoting international sharing of knowledge and insight.

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.