Parexel Regulatory Outsourcing Services is “meant to capitalise on an emerging industry trend around life cycle management associated with marketed products,” freeing clients to spend time and money on other projects, Ingo Bank, Chief Financial Officer, told Outsourcing-Pharma.com.
“Pharmaceutical companies are under pressure to become more efficient. A not insignificant percentage [of budget] is spent within pharmaceutical companies in general on regulatory activities.”
Parexel’s existing consulting practice helps companies with regulatory strategies, such as how and when to talk to regulators, and the approval process during trials. But this latest service, headed by corporate VP Rick Riegel, is aimed at clients after their drug has been approved, providing help with the publication and submission of documents to the regulatory authorities, Bank said.
“This service line is an offering for post-approval regulatory activities – fairly repeatable in nature – of lower risk to our clients.”
‘More meaningful’ work
When it comes to post-market approval regulatory activities, there are already a small number of “niche providers that help pharmaceutical companies with individual small service lines, such as medical writing, but there’s not yet a full-blown end service,” Bank told us.
Most regulatory work on already marketed drugs is currently done by internal staff at pharmaceutical companies. This includes observational activities and updating documents with regulatory authorities if changes are made to the manufacturing process.
“We basically release pharmaceutical companies from the majority of these post-approval regulatory activities and organise them in a cost-effective way, so they can redirect their internal resources to other needs, not necessarily regulatory in nature, but more meaningful,” Bank told us.
Bank said the acquisition one year ago of Liquent , a provider of regulatory information management (RIM) tools, provided Paraxel with the technology and operational know-how to provide the outsourcing of dossier management.
Parexel’s regulatory service uses Liquent’s RIM platform, named Liquent InSight, Bank said, to “handle documents flow, efficiently update product documents, file documents electronically fashion – so you can show regulatory authorities that documents are always updated.”
Demand for third-party post-market regulatory activities ties into a larger trend for increased outsourcing, Bank told us.
“Pharmaceutical companies are starting to examine their core activities to see what they can possibly outsource.
“Where drugs are already on the market, regulation – such as updating document files – is a fairly intense activity with high repeat business. We have the technology and the global footprint and take this burden away from pharmaceutical companies.”
Demand for outsourcing is also increasing as a response to the complications of the global market, especially when companies launch drugs in multiple countries, Bank told us.
“Increasingly because of the globalisation of trials and regulatory efforts, it’s becoming more complex for our clients to deliver a drug to the market or to a number of markets. It’s overall becoming a bigger journey, and regulatory services are part of the journey.”