How global air cargo trends are reshaping pharmaceutical transport
As we welcome the new decade and the exciting advances it’s expected to unleash, many of the forces that shaped the past decade for transporting pharmaceuticals will continue. Price pressures, alternatives to air freight and increasing automation are just a few. However, there are emerging trends that make 2020 unique
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British Cannabis chooses Shimadzu cannabis analyzer to enhance QA
British Cannabis, manufacturer of cannabis oils for food supplements, has introduced Shimadzu's Cannabis Analyzer to ...
FDA approves Xellia US facility for CMO injectables
The increased capacity will be used to grow and scale Xellia’s own pipeline as well as widening its offering of CMO ...
Challenging agency guidance: what to do when NICE gets it “wrong”
Catherine Penny, Managing Associate at law firm Stevens & Bolton, offers advice regarding how healthcare organisations ...
Transforming the performance of batch production
An ever-increasing number of businesses, particularly in the oral solid dosage (OSD) sector are boosting their ...
Albumedix establishes new regulatory department following DMF acceptance
One of six main centres for the US FDA has accepted a Drug Master File (DMF) submission for the Albumedix’s ...
FDA approves new facility for Pharming Group biologic production
Netherlands-based pharmaceutical company has received approval to expand production of angioedema biologic in the ...
Optimise desiccants with 3D validation software
Baltimore's CFD model brings predictive science to validation. Desiccants are tested for performance over time, ...
FDA releases final guidance for upcoming biological product transition
The BPCI Act requires that a marketing application for a “biological product” must be submitted as a biologics ...
MedPharm completes successful FDA inspection at US centre of excellence
The inspection coincides with the recent expansion of MedPharm's facilities to triple its footprint and accommodate up ...
Nitrosamines: Information for Marketing Authorisation Holders
Nitrosamine impurities have been in the regulatory spotlight since they were discovered in several blood pressure ...
IntelGenx: oral films are drug development’s patent trick
Exploiting improvements in bioavailability, the Canadian company has developed unique oral film technology to help ...
Data integrity compliance for chromatography methods
The ability to track and trace information from one laboratory to another across the globe is challenging but doable, ...
Ellutia emphasises nitrosamine testing as EMA deadline draws near
From April 2020 all marketing authorisation holders of medicines containing chemically synthesised APIs must conduct a ...
Catalent client gets FDA approval for generic bronchodilator
Approval has marked the first generic metered-dose inhaler to be approved by the FDA in over twenty years and will now ...
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