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How Accumulus’s ‘Dossier In The Cloud’ Platform Is Modernizing ‘Inefficient’ Drug Regulation

 
• By Eliza Slawther

Global non-profit Accumulus Synergy wants to remove “unnecessary complexities and inefficiencies” in the regulatory process with its cloud-based communication platform, the corporation’s CEO and chief regulatory innovation officer tell the Pink Sheet.

Cloud Computing
• Source: Shutterstock

The way that pharmaceutical companies and regulators across the globe exchange information is “no longer fit for purpose” and needs a significant change, according to Francisco Nogueira, CEO of the non-profit technology organization Accumulus Synergy. 

“At the most basic level, we bring together those who develop medicines and those who review and approve them in a common place, so that the communication and data exchange...

Key Takeaways

  • Accumulus Synergy’s cloud-based regulatory platform is intended to make data sharing between regulators and sponsors easier and more modern.

  • The platform has launched and...

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More from Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.