Pharmacy Market

Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals

May 11, 2022

Essential for
CDER is taking another step towards realizing the vision for pharmaceutical quality in the 21st century: a maximally efficient, agile, flexible manufacturing sector that reliably
produces high-quality drug products without extensive regulatory oversight.

Spotlight

Synchrogenix, a Certara company

REGULATORY and MEDICAL WRITING By merging our cross-functional expertise with our writing experience, we deliver documents that not only support clients’ strategic messaging, but also enhance their marketability. We provide many of the benefits of in-house writers including the experience and perspective of industry insiders without increased overhead or struggles with fluctuating workloads.

OTHER WHITEPAPERS
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MEETING CURRENT AND FUTURE SERIALISATIONCHALLENGES

whitePaper | December 5, 2022

Serialisation has emerged as a complex challenge for the pharmaceuticals sector which is facing a multiplicity of differing regulations that vary from one country to another.

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High Pressure Homogenizer for Nano-formulation

whitePaper | December 16, 2022

NanoGenizer, a lab-scale microfluidic high pressure homogenizer, utilizes interaction high-pressure microfluidic jet technology, and it is equipped with highly modular power and processing units.

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Getting serious about serialization: A comprehensive look at thelegislation shaping U.S. pharmaceutical supply chains

whitePaper | October 7, 2022

The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain.

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Achieving diversity, equity and inclusion in clinical trials

whitePaper | April 26, 2022

The prevalence of communicable and non-communicable diseases are increasing worldwide, placing considerable demand on public health systems and driving a necessity to develop more effective targeted therapies.

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Overcoming Pharma’s Launch Performance Problem

whitePaper | March 24, 2023

The prescription medicine market recovered from the wild swings of the early pandemic with renewed volume growth, driven by generics. COVID-19 vaccines and treatments have created a substantial market.

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Non-Clinical Testing Considerations: Drugs vs Devices

whitePaper | November 8, 2022

While drugs and devices differ in their development, clinical trial phases and regulatory guidelines, the most important difference is that medical devices do not achieve their principal action by pharmacological means.

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Spotlight

Synchrogenix, a Certara company

REGULATORY and MEDICAL WRITING By merging our cross-functional expertise with our writing experience, we deliver documents that not only support clients’ strategic messaging, but also enhance their marketability. We provide many of the benefits of in-house writers including the experience and perspective of industry insiders without increased overhead or struggles with fluctuating workloads.

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