Industry Insights
-
4 Ways To Gain A Competitive Edge In This Bio/Pharma Talent Shortage
8/25/2023
It’s no secret that finding pharma/biotech manufacturing talent is challenging, and the lack of workers is having a negative impact on productivity and growth. Here are four effective strategies for recruiting, training, educating, and retaining your workforce.
-
MHRA’s Compliance Report
3/26/2013
On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. By Bart Cobert
-
The Cancer Drug Shortage: When Quality Fails
7/7/2023
Our industry is failing cancer patients with the current cancer drug shortage. Why is this happening and what can we do about it? This expert provides her insights from the perspective of a quality control professional.
-
How Does The FDA's Process Validation Guidance Simplify A Technology Transfer?
8/3/2016
-
Tablet Compression Tooling: Land Or No Land?
7/6/2022
Explore why tablet land, the horizontal surface perpendicular to the tablet's periphery, should be designed using a holistic approach.
-
Drug Repurposing Advantages And Strategies
Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.
-
Liposome Vs. Lipid Nanoparticle: What's The Difference?
8/10/2022
Here, we discuss the differences between nanoparticles and liposomes along with their applications in medicine.
-
FDA’s First DSCSA Warning Letter — A Closer Look
3/11/2019
The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.
-
Incorporating Privacy By Design & Security By Design Into Medtech Development
9/2/2020
Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.
-
Process Development With “The End In Mind” For Startups
3/20/2024
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.