The Cambridge, UK-headquartered pharma services firm ELC has signed a contract with an undisclosed Chinese active pharmaceutical ingredient (API) maker worth €1.5m ($1.6m) for its regulatory affairs consultancy services.
ELC is contracted to help take two of the pharma firm’s antispasmodic orally dispersible tablet products through to commercialisation in Western markets (including the US and EU) using its regulatory affairs consultancy service, a service Akhil Jain, VP Strategic Alliances and Business Development at ELC, said has high demand among Asian drugmakers.
“Asian organisations conduct business quite different from the EU or other western organisations, there is significant cultural gap that needs to be bridged before any business can commence,” Jain told Outsourcing-Pharma.com.
“The main challenges are the complexity of regulatory environment, cross-cultural barriers,” including problems with language, business practices, and trust issues, he said, while adding GMP manufacturing standards is another serious challenge.
“Chinese and many other Asian companies require long term hand holding starting from preparing their manufacturing sites to be able to comply with GMP guidelines of the regulated world, education and training the workers to think internationally and understand and believe in the values of GMP.”
Outsourcing demand
ELC is working with most of the top 50 Pharma companies in China and Jain attributes this – as well as the latest win which pitted ELC against three other CROs – to the firm’s “business model which integrates R&D, Clinical services, regulatory filings and business development on one single platform.”
He also explained why choosing a market expansion firm could be a preferred option to setting-up such a unit in-house, citing the large cost, difficulty in finding staff with the relevant language skills and the feasibility for companies with a limited portfolio of products.
“It is like reinventing the wheel at a time when all major pharma companies are now downsizing their regulatory and market expansion operations globally and outsourcing these processes to organisation such as ELC.”