Contract development and manufacturing organisation (CDMO) Recipharm has partnered with product development and regulatory affairs service provider ProductLife Group (PLG) to support (bio)pharmaceutical companies in expediting market approval and trial time.
This partnership aims to address the challenges in supply chain, compliance and regulatory affairs during product development.
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It combines Recipharm’s fully integrated development and manufacturing portfolio, including traditional biologics, advanced therapies medicinal products (ATMPs) and small molecules, with PLG’s knowledge in product development, market access and regulatory affairs.
Recipharm noted this integration ensures that customers are supported from the early stages of development through to approval and market access, potentially leading to earlier market availability of medicines.
The collaboration will provide Recipharm customers with immediate access to PLG’s product development expertise, along with its experience in worldwide regulatory affairs, market access and pharmacovigilance.
With PLG’s integration, pharma and biotech firms will be able to align their product development, regulatory and market access plans from the outset, maintaining control throughout the product scale-up and manufacturing processes.
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By GlobalDataIn turn, PLG’s clients will benefit from access to the manufacturing infrastructure of Recipharm, which includes integrated development, manufacturing support for rapid development, and predictive models for biologics production and release.
Recipharm CEO Greg Behar said: “This partnership brings together Recipharm’s development and manufacturing expertise, with PLG’s 2,000 regulatory experts, operating across 150 countries.
“By integrating scientific, regulatory, operational and commercial strategy from the outset, we help our customers move faster, avoid costly delays and build confidence that their product submissions will meet and exceed agency requirements for critical medicines worldwide.”
Last October, PLG acquired IntiQuan, a Swiss company specialising in pharmacometrics.
