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Results For "regulatory"

1129 News Found

Rockwell Automation empowers NKP Pharma achieve regulatory compliance
Digitisation | April 17, 2025

Rockwell Automation empowers NKP Pharma achieve regulatory compliance

By integrating Rockwell Automation’s FactoryTalk Optix, NKP Pharma has achieved compliance with USFDA 21 CFR Part 11


India reaffirms commitment to global pharmaceutical standardization and regulatory convergence: Anupriya Patel
Policy | February 06, 2025

India reaffirms commitment to global pharmaceutical standardization and regulatory convergence: Anupriya Patel

International Meeting of World Pharmacopoeias serves as a vital platform to foster international collaboration in pharmacopoeial science and regulatory harmonization


ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility
Drug Approval | December 21, 2024

ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility

The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe


Azenta obtains regulatory approval for clinical long-read whole genome sequencing test
Biotech | November 22, 2024

Azenta obtains regulatory approval for clinical long-read whole genome sequencing test

Performed within GENEWIZ from Azenta Life Sciences' CLIA-certified and CAP-accredited state-of-the-art clinical genomics laboratory


7th India-Japan medical product regulatory symposium held at New Delhi
Policy | July 14, 2024

7th India-Japan medical product regulatory symposium held at New Delhi

Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations


Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
Drug Approval | July 03, 2024

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population


GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Drug Approval | April 17, 2024

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met


Venus Remedies secures regulatory approvals for three key oncology drugs in Ukraine
News | March 19, 2024

Venus Remedies secures regulatory approvals for three key oncology drugs in Ukraine

Ukrainian marketing approvals for paclitaxel, oxaliplatin and irinotecan mark a significant milestone in the company’s global expansion strategy


Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment
Drug Approval | December 26, 2023

Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results


Pfizer receives regulatory approvals to complete the acquisition of Seagen
News | December 13, 2023

Pfizer receives regulatory approvals to complete the acquisition of Seagen

Announces changes in the commercial organization to incorporate Seagen and improve focus, speed and execution