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Results For "regulatory-affairs"

64 News Found

Amaran Biotech signs MOU with Nippon Fine Chemical to expand CDMO business
News | March 08, 2025

Amaran Biotech signs MOU with Nippon Fine Chemical to expand CDMO business

Amaran Biotech boasts Taiwan’s first fully automated robotic aseptic filling line, offering high-quality and low-waste filling solutions for high-value pharmaceuticals


Emcure Pharmaceuticals inaugurates R&D centre in Ahmedabad
News | January 24, 2025

Emcure Pharmaceuticals inaugurates R&D centre in Ahmedabad

The Emcure Research Centre (ERC) will drive research across multiple dosage forms, including OSD, injectables, novel drug delivery systems (NDDS), inhalers and topical and transdermal formulations


Akums appoints Shantanu R Chobhe as Corporate Quality Assurance Head
People | September 05, 2024

Akums appoints Shantanu R Chobhe as Corporate Quality Assurance Head

Chobhe brings over 30 years of extensive experience in quality and regulatory management within the pharmaceutical industry


Honeywell launches quality management system HQMR for Life Sciences industry
News | August 26, 2024

Honeywell launches quality management system HQMR for Life Sciences industry

Honeywell Quality Management Review helps manufacturers boost efficiency and quality compliance


Aptar’s nasal unidose system delivers FDA-approved neffy
News | August 19, 2024

Aptar’s nasal unidose system delivers FDA-approved neffy

This marks the first regulatory approval worldwide for nasally-delivered epinephrine


Elucid appoints Kelly Huang as CEO
People | July 22, 2024

Elucid appoints Kelly Huang as CEO

Experienced commercial leader takes helm to expand cardiovascular diagnostic company globally and commercialize company’s flagship plaque analysis software


AbbVie appoints Roopal Thakkar as EVP, Research & Development and Chief Scientific Officer
People | July 10, 2024

AbbVie appoints Roopal Thakkar as EVP, Research & Development and Chief Scientific Officer

Dr. Roopal Thakkar joined Abbott/AbbVie in 2003 as part of the Physician Development Program


USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria
News | April 17, 2024

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections


Qure.ai adds new FDA breakthrough device status for qSpot-TB
Digitisation | February 09, 2024

Qure.ai adds new FDA breakthrough device status for qSpot-TB

4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months


Biocon Academy conducts 8th Graduation Day
News | December 19, 2023

Biocon Academy conducts 8th Graduation Day

Five batches across four programs of Biocon Academy participated in the graduation ceremony