regulatory affairs strategy

3.17.2014 Regulatory Affairs

Manage Regulatory Intelligence Groups to Stay Ahead of New Regulatory Guidelines

By Jacob Presson, Research Analyst The rapid pace that regulatory guidelines are updated around the world can be dizzying for even some large and established regulatory affairs groups to keep up with.  A well-managed regulatory intelligence group...
 

1.31.2014 Quality Control and Assurance

Pharma Companies Increase Cross-Functional Communication with Regulatory Affairs Teams

By Yanis Saradjian, Director of Consulting The last 10 years have seen regulatory affairs groups evolve from a group focused on submitting new drug applications and coordinating communication with regulatory agencies.   Regulatory groups now expect...
 

1.22.2014 Regulatory Affairs

The Regulatory Hokey Pokey

By Jacob Presson, Research Analyst Many readers will be familiar with the children’s dance song “The Hokey Pokey” (or “Hokey Cokey” for our UK-based readership) which instructs participants to, “put your right arm in, put your right...
 

1.20.2014 Regulatory Affairs

Three Steps Toward a Successful Regulatory Affairs Operation

By Jacob Presson, Research Analyst As regulatory affairs groups in the pharma industry continue their shift into more strategic roles with greater influence on product development, it is vital that these groups are structured efficiently and communicate...
 

11.26.2013 Drug Safety

Improving Drug Safety: The Drug Quality and Security Act

By Sarah Ray, Research Analyst Recent events have highlighted the need for increased government regulations to uphold the pharmaceutical supply chain and improve existing drug safety measures. Since the contamination of steroidal injections in 2012...
 

8.29.2013 Regulatory Affairs

The [Regulatory] Times, They Are A-Changin’

By Jacob Presson, Research Analyst Regulatory affairs groups in the pharmaceutical industry have been going through a fast-paced evolution over the past 10 years.  It wasn’t that long ago that these groups were almost taken for granted in the...
 

8.22.2013 Drug Safety

Pharma and the Environment: A Different Kind of Drug Safety

By Sarah Ray, Research Analyst In recent years, environmental concerns have made their way to the forefront of current issues — supported by scientists and politicians alike.  As far as pharma is concerned, environmental regulations are nothing...
 

7.16.2013 Pipeline Planning

The Debate on ‘Pay-for-Delay’ and Anti-Trust Laws

By Jennifer Harrell, Research Analyst “Pay-for-delay” deals face increasing regulatory scrutiny, although the details of their true economic implications remain murky. These deals – often the result of painstaking litigation – allow branded...
 

1.14.2013 Sales

Price Accountability Comes to Sales Reps via Affordable Care Act

The Affordable Care Act’ (ACA) ride through legislative and judicial hurdles has focused on the high profile aspects of the law including the insurance mandate and state Medicaid responsibilities.  However, one part of the law that will have a major impact on...
 

11.7.2012 Regulatory Affairs

Longer regulatory approval timelines? It’s not all FDA’s fault.

Many small pharmaceutical companies and biotech manufacturers continue to struggle with FDA approval delays that have developed over the past several years. Even internationally, regulatory guidelines have evolved to the point of being outright onerous in some...