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Tag: regulatory affairs

Healthy.io and Boehringer partner on at-home testing for CKD

<!----> Healthy.io has collaborated with Boehringer Ingelheim Pharmaceuticals to launch an at-home testing programme for patients with chronic...

MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

  WASHINGTON, May 8, 2023 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating...

Strong compliance and rigorous risk management can help, not hinder, growth

The following is a guest post by Jonathan Polk, General Counsel and Chief Compliance Officer at Melio. Startups bringing innovative products to market face...

Centralized intermediaries were cause of crypto failures in 2022, says Voorhees

The past year has been the “worst” in crypto history in terms of negative headlines, but most of the problems were caused by centralized...

QuidelOrtho gets FDA authorisation for Sofia 2 antigen test

<!----> QuidelOrtho has received De Novo authorisation from the US Food and Drug Administration (FDA) for its Sofia...

Tech Jobs: Want To Save The World? These Recently Funded Clean Energy Startups Are Hiring 

The question on (almost) everyone’s mind in the startup and venture world is which sectors will not only survive during this ongoing downturn,...

Transformational Relationships: How a Consultative Approach from a CRO Adds Value to Your Development Program

March 1, 2023 The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which...

Space launch firms seek to balance government, commercial client needs

WASHINGTON — Space launch company executives said this week that as they serve an increasingly diverse mix of government and commercial customers, striking a...

Ibex gets CE mark for Galen Prostate diagnostics platform

<!----> Ibex Medical Analytics has received CE mark for its pathology diagnostics platform, Galen Prostate, under the European...

Ampersand Portfolio Company Sterling Medical Devices Recapitalizes RBC Medical Innovations, Merges Entities

Creates Electromechanical Medical Device Industry Leader with Broad Design, Development, Regulatory and Manufacturing Capabilities Industry Veteran David Montecalvo Appointed CEO of Combined Company,...

ComplyAdvantage sees worsening conditions in 2023 financial crime report

Rampant financial crime is becoming a common theme of news stories. High-profile scandals aside, the financial community is living under the ever-present threat...

Strategies to Maximize Outcomes During Pre-Submission Meetings

Pre-submission meetings are a good opportunity to interact with regulators, educate them on your technology and gather valuable feedback for your submission.However, if not...

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