Woodley BioReg is pleased to announce a strategic partnership with US-based Regulatory Strategic Solutions (RSS). This collaboration marks a significant milestone for Woodley BioReg, expanding its footprint into the United States and reinforcing its commitment to supporting drug, device, and biologic companies in accelerating their path to market.

Regulatory Strategic Solutions (RSS) is a renowned consultancy dedicated to guiding companies through the complex regulatory and oversight processes of the Food and Drug Administration (FDA). RSS professionals, with decades of experience, have built a solid reputation working with both US and global companies in the drug and biologics sectors, expediting product development and securing regulatory approval.

By partnering with RSS, Woodley BioReg strengthens its ability to provide comprehensive, tailored regulatory strategies that align with client business goals, budgets, and timelines. This partnership is a natural synergy, as both organisations support the pharmaceutical, medical device, and biologics sectors, positioning them at a more competitive level within the industry. Together, they will leverage their combined expertise to help clients effectively engage with the FDA and ensure their products meet all necessary regulatory requirements.

“We are thrilled to partner with Regulatory Strategic Solutions as we expand our reach into the US market,” said Ash Ramzan, founder of Woodley BioReg. “RSS’s extensive experience and proven track record in FDA regulatory matters complement our existing services, enhancing our ability to support our clients through every step of the regulatory process, from early development to market entry.”

Regulatory Strategic Solutions offers a wide range of services, including: US Agent and Regulatory Representation; eSubmissions management and liaison; and Program and product development gap assessments and solution implementation.

“Our collaboration with Woodley BioReg represents an exciting opportunity to broaden our reach and impact in the regulatory consultancy space,” said Joan Lawson, President of Regulatory Strategic Solutions. “Together, we will deliver unparalleled strategic guidance, helping clients navigate the complexities of FDA regulatory requirements with confidence and efficiency.”

The partnership is designed to not only facilitate success with FDA regulatory approvals but also to support early and mid-stage funding rounds, government and special interest investments, and corporate and investor partnerships.

This new alliance positions Woodley BioReg and RSS to deliver exceptional value to their clients in the highly regulated pharmaceutical, device and biologic industries, providing the expertise and support needed to bring innovative therapies to patients faster.

For more information on how Woodley BioReg and Regulatory Strategic Solutions can support your regulatory strategy and expedite your product’s path to market, please get in touch.


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