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CorMedix sees NDA approval delay due to CMO and API supplier issue

A Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed t...

Closing the skills gap in manufacturing and engineering

It’s no secret that UK engineering and manufacturing are suffering a massive skills shortage; although open positions remain unfilled in many secto...

Have you got screen fatigue?

Read Manufacturing Chemist in print, at your leisure

Automation’s role in supporting regulatory operations

Robotic process automation (RPA) offers a cost-effective solution to laborious and repetitive document and data processing

Polpharma Biologics announces FDA file acceptance for review of natalizumab

Polpharma Biologics announces that the US Food and Drug Administration (FDA) has accepted the first-ever Biologics License Application (BLA) for na...

Risk-based process design and advanced control technologies are key to cost-efficient sterile injectable manufacturing

The industry generally understands that creating and maintaining aseptic sterile injectable (SI) processing environments is technically and financi...

How can you create a secure supply chain?

For many businesses, the supply chain is essential and operating a secure logistics operation is critical to success. Without measures in place to...

The new regulatory world for medical devices

Establishing an effective compliance strategy now ahead of the 2022 IVDR legislation is critical — because there’s more to come

Lonza and Adva reach agreement on bioreactor patents

Lonza and Adva Biotechnology have resolved their related patent litigation in the US

2D codes: preparing for the new dimension

After successful implementation in sectors including tobacco and pharmaceuticals, two-dimensional barcodes or 2D codes are gaining prevalence acros...

ICH Q12 toolbox and change management

With present day circumstances including the pandemic affecting almost all sectors of society, the pharmaceutical industry is gravitating towards a...

Deciding on a chemistry, manufacturing and control strategy for biologic development

Khanh Ngo Courtney from Avomeen discusses what biopharmaceutical companies should keep in mind as they embark on their CMC journey

MHRA joins international partnerships to set global standards for medicines and medical devices regulation

The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the...

How can my business improve environmental management?

Did you know that, according to the World Meteorological Organisation (WMO), temperatures were around 1.09 °C higher than the 1850-1900 period from...

Merck announces collaboration with Agilent to fill PAT gap for downstream processing

Collaboration will help to enable real-time release and Bioprocessing 4.0

Supporting global decentralised and virtual clinical trials during challenging times and beyond

Decentralised clinical trials (DCTs) utilising direct-to-patient (DTP) services, including the provision of drug products, ancillary supplies and h...