Regulatory

Serialisation master data

There are high risks associated with managing master data if the organisation does not have the right tool or personnel managing the system, CosmoTrace looks at the importance of data

Breaking News

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...

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...

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...

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

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

Austar wins validation services contract for recombinant protein COVID-19 vaccine project

AUSTAR Compliance Consultancy Service has been awarded the validation consultancy services contract for the company's recombinant protein COVID-19...

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...

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

Agilent collaborates with APC on real-time process monitoring

The two companies have committed to combining their technologies to provide unique workflows to customers that support automated process analysis v...

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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...

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

Anticipate future challenges early, Pharmatech urges

”Don’t be left short-changed post approval – plan in change orders early for accelerated pathways,” Stephanie Gaulding said in her keynote address...

How can we ensure compliance with the revised Annex 1?

Christian Dunne, Head of Sterility Assurance at ChargePoint Technology, explores what the industry can expect to see in the new Annex 1 legislation...

Pharmapack Europe 2022 award winners announced

A record number of commendations were awarded by the judges, based on the overall high standard of entries

Why outsourcing makes sense for orphan and rare diseases

There are as many as 8000 rare diseases, affecting 400 million people worldwide, for which there are no effective drugs available.<sup>1</sup> With...