Process Validation, the Bedrock of Success
Design validation is a critical regulatory requirement, which if done systematically, sets a strong foundation in the success of launching a new medical device to market, while ensuring that the device meets user needs.
In...
Building a Solid Foundation in Medical Device Packaging
Medical device development is a long journey consisting of preliminary bench testing, multiple cycles of ‘build-test-fail-redesign’ and taking the product concept from Research and Development (R&D) to production. Other steps include analyzing the economic...
Particle analysis: Growing demand with biologics
The development and introduction of new biological drug substances has been on the rise, and so have the regulatory requirements placed on these often life-saving products. At the same time, innovative analytical technologies have...
The current scenario in Pharmaceutical Packaging Development
Ultra high barrier films protect any dosage content
The Pharmaceutical Industry has always mainly focused on novel drug research, formulation development, and subsequent clinical trials. As with all other phases it presents its own challenges....
The use of positron emission tomography-computed tomography (PET/CT) to assist preclinical oncology research
Positron emission tomography (PET) is a popular nuclear imaging technique used to gain information about specific molecular biomarkers. It is often combined with other imaging technologies, such as magnetic resonance imaging (MRI) and computed...
Drug-Eluting Devices: Delivering on Drug Delivery’s Combined Potential
Implantable drug-eluting devices (DEDs) have come a long way since 1938, when Finland approved a subcutaneously administered birth control device delivering levonorgestrel.
Over their development history, the therapeutic performance and value of DEDs has evolved...
A Powerful Pairing: Academia-Industry Collaborations for Pharmaceutical Innovation
Innovation is unarguably the essence of pharmaceutical discovery and development. Industry and academia have been working together for decades, but historically relationships did not extend far beyond the traditional exchange of funding and research....
Top Three Considerations for Purchasing Antibodies
Antibodies are widely used in pre-clinical research to study proteins and their functions in biological pathways and diseased states. These tools, with their high specificity and sensitivity, help life science researchers to easily identify...
Steps to Compliance: How Best to Prepare for Russia’s 2020 Pharma Regulations
Preparing for Russia’s regulation requirements might seem like a mountain to climb, but it’s a necessary journey for companies that want to remain in or enter the 10th largest pharmaceutical market in the world.
With...
Data Collection in Phase II-III Clinical Research – It is Ripe for Disruption?
Current data collection practices in clinical research are facing many challenges. There is a broad recognition that issues prevail with the current clinical research data collection processes and systems.
Industry leaders, such as Janet Woodcock,...