Pharmacy Market

Introducing EU Annex 1: Understanding the Newest Regulatory Requirements

July 1, 2023

Introducing EU Annex
As its title implies, Annex 1 is the European guidance document for good manufacturing practices of medicinal products. As such, it serves as the road map for sterile drug manufacturers to follow in order to arrive at the pathway to the highest level of sterility, assuring that their medicinal drug products deploy operational best practices, are certifiable, and regulatorily safe.

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Regulatory Affairs Associates

RAA provides invention to approval regulatory consulting in toxicology, formulation, clinical trial management, manufacturing, engineering, and business planning.

OTHER WHITEPAPERS
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Redefining the Role of Health Systems as a Specialty Pharmacy Solution for Drug Manufacturers

whitePaper | January 10, 2023

The ideal care model for complex patients is a model in which the entire health care team is made up of experts in the specific disease state being treated. Integrated health care systems and major academic medical centers provide this level of expertise and coordination.

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Overcoming technical challenges in cell-based high throughput screens

whitePaper | November 11, 2022

Tremendous technological advancements in automated biotechnology and combinatorial chemistry have led to the widespread implementation of high throughput screening (HTS) for drug discovery since the early 1990s.

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The Age of Coaching

whitePaper | March 4, 2022

The pandemic has been healthcare and the pharmaceutical industry’s meteor moment established eco-systems have been wiped out andsales force routines have been scorched from the face of the earth.

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Adapting to Pharma’s Next Normal

whitePaper | October 4, 2022

Let’s just say what we’re all thinking: 2020 was rough. It threw every element of our lives into disarray. We suddenly had to become experts at navigating a new way of working, schooling and socialising. It was disruptive and it was challenging, but it was also transformative

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Market Access Trends in the US, Europe, and Emerging Markets

whitePaper | November 14, 2022

Rising drug spending and increased desire for expenditure controls are consistent themes across the US, Europe, and emerging markets.

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The Use of Real-World Data for Personalized Medicine

whitePaper | June 5, 2022

Although our growing scientific understanding and improvements made in medical technology lead to significant advances in human health and wellbeing, many therapy strategies remain insufficient,

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Spotlight

Regulatory Affairs Associates

RAA provides invention to approval regulatory consulting in toxicology, formulation, clinical trial management, manufacturing, engineering, and business planning.

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