The Contract Development and Manufacturing Organization (CDMO) COPEMHARM has partnered with product development and regulatory affairs service provider Product Life Group (PLG) to support (BIO) pharmaceutical companies to accelerate market approval and trial time.
The partnership is designed to address the challenges of supply chain, compliance and regulatory affairs during product development.
It combines a fully integrated development and manufacturing portfolio of formulas, including traditional biologics, advanced therapies (ATMPs) and small molecules, as well as PLG’s knowledge in product development, market access and regulatory affairs.
ConfeMharm notes that this integration ensures support from customers from early stages of development to approval and market acquisition, which may lead to an earlier market supply of medicines.
The partnership will provide Conseharm customers with immediate access to PLG’s product development expertise, as well as its experience in global regulatory affairs, market access and drug advocacy.
Through PLG's integration, pharmaceutical companies and biotech companies will be able to align their product development, regulatory and market access plans from the outset, thus maintaining control throughout the product expansion and manufacturing process.
In turn, PLG customers will benefit from accessing Coperamharm’s manufacturing infrastructure, which includes integrated development, rapid development of manufacturing support, and predictive models for biomassing and distribution.
"This partnership brings together Copharma's development and manufacturing expertise, with PLG's 2,000 regulatory experts operating in 150 countries," said Greg Behar, CEO of COPECHARM.
“By integrating science, regulatory, operational and business strategies from the outset, we can help customers move faster, avoid expensive delays, and establish confidence that their product submissions will meet and exceed the proxy requirements of critical drugs worldwide.”
In October last year, PLG acquired Intiquan, a Swiss company, specializing in pharmacometrics.
Originally created and published by GlobalData-owned brand Pharmaceutical Technology: “to support pharmaceutical companies to accelerate market approvals to support pharmaceutical companies’ food and PLG.”
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