COVID’s Impact on Innovations in Regulatory Affairs

While the impact of COVID-19 was significant in every area of the pharmaceutical sector, some of the most pandemic’s most overlooked impacts were within the regulatory space. From study design to submissions, the virus affected every aspect of drug regulation,...

4 months ago
Bioprocess,Regulatory Affairs,News

COVID’s Impact on Innovations in Regulatory Affairs

While the impact of COVID-19 was significant in every area of the pharmaceutical sector, some of the most pandemic’s most overlooked impacts were within the regulatory space. From study design to submissions, the virus affected every aspect of drug regulation,...

4 months ago

The Future of CMC: An Interview with Jean-Pierre Metabanzoulou

The need to ensure patient safety and drug efficacy in pharmaceuticals is only increasing. With the sudden disruption caused by the COVID-19 pandemic, the Chemistry and Manufacturing Controls (CMC) process has been thrown into the spotlight as critical to drug...

11 months ago
Biomanufacturing,CMC,Regulatory Affairs,News

The Future of CMC: An Interview with Jean-Pierre Metabanzoulou

The need to ensure patient safety and drug efficacy in pharmaceuticals is only increasing. With the sudden disruption caused by the COVID-19 pandemic, the Chemistry and Manufacturing Controls (CMC) process has been thrown into the spotlight as critical to drug...

11 months ago

Better CMC Organisation in Small Pharma Drug Development

Chemistry, Manufacturing and Controls (CMC) is a vital part of the drug development process. A CMC strategy gives companies a template for bringing a drug through the early clinical stages all the way to commercial manufacturing.  The CMC process has...

1 year ago
Bioprocess,Biomanufacturing,CMC,Regulatory Affairs,News

Better CMC Organisation in Small Pharma Drug Development

Chemistry, Manufacturing and Controls (CMC) is a vital part of the drug development process. A CMC strategy gives companies a template for bringing a drug through the early clinical stages all the way to commercial manufacturing.  The CMC process has...

1 year ago

Solving Regulatory Issues in Cell and Gene Therapies

Cell and Gene Therapies (CGTs), experimental technologies to treat or cure diseases using the body’s cells, have been on the ascendant for some time now. As promising as they are, CGTs have consistently moved forward faster than regulatory agencies can...

1 year ago
Bioprocess,CGT,Biomanufacturing,Regulatory Affairs,News

Solving Regulatory Issues in Cell and Gene Therapies

Cell and Gene Therapies (CGTs), experimental technologies to treat or cure diseases using the body’s cells, have been on the ascendant for some time now. As promising as they are, CGTs have consistently moved forward faster than regulatory agencies can...

1 year ago

How will COVID-19 Change Biomanufacturing?

The COVID-19 pandemic proved how ill-equipped the world was for a virus of that scale and potency. In the first months of the pandemic, businesses across all sectors scrambled to prepare their processes and supply chains for the coming disruption,...

1 year ago
Bioprocess,CGT,Biomanufacturing,Regulatory Affairs,News

How will COVID-19 Change Biomanufacturing?

The COVID-19 pandemic proved how ill-equipped the world was for a virus of that scale and potency. In the first months of the pandemic, businesses across all sectors scrambled to prepare their processes and supply chains for the coming disruption,...

1 year ago

The Challenges of CMC in Cell and Gene Therapies

Safety is one of the most important aspects of drug development. The need for a drug to be efficacious, consistent and non-harmful to humans is vital for its success. And where a treatment is new, highly variable, and can involve...

1 year ago
Bioprocess,CGT,Biomanufacturing,CMC,Regulatory Affairs,News

The Challenges of CMC in Cell and Gene Therapies

Safety is one of the most important aspects of drug development. The need for a drug to be efficacious, consistent and non-harmful to humans is vital for its success. And where a treatment is new, highly variable, and can involve...

1 year ago

Google – The New Pharmaceutical Regulator?

Last Friday, Google stated in a press release that it would no longer be accepting advertisements for “speculative and experimental medical treatments”, including most stem cell or gene therapies, after observing unscrupulous companies taking advantage of patients through offers of...

2 years ago
Bioprocess,Regulatory Affairs,News

Google – The New Pharmaceutical Regulator?

Last Friday, Google stated in a press release that it would no longer be accepting advertisements for “speculative and experimental medical treatments”, including most stem cell or gene therapies, after observing unscrupulous companies taking advantage of patients through offers of...

2 years ago