Quality & Compliance
What is GxP Compliance: A Detective’s Guide to Quality and Regulatory Compliance
Introduction In the brightly lit corridors, clean rooms, and warehouses of pharmaceutical and medical device industries, a mystery lurks—a puzzle shrouded in regulations, veiled in risk, and cloaked...
Quality & Compliance
EU Pharmaceutical Legislation Revisions FAQ
On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following...
Quality & Compliance
Navigating EU GMP Compliance: A Consultant's Guide to Smooth Sailing
Hello, fellow pharma enthusiasts! In the fast-paced world of pharmaceuticals, ensuring Good Manufacturing Practice (GMP) compliance is essential to maintaining product quality and safety. The...
Quality & Compliance
Building Clinical Quality Assurance: Unlock the Full Potential of Your Clinical Development
In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic. With...
Quality & Compliance
Staying GMP Compliant: A Consultant's Guide to Compliance Bliss
Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...
Quality & Compliance
Ensuring Quality in Clinical-Phase Drug Manufacturing: A Comprehensive Guide
Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry, ensuring that every aspect of drug manufacturing...
Quality & Compliance
15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?
Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific...
Quality & Compliance
5 Key Challenges in the Development of Gene Therapies
Over three decades of gene therapy (GT) clinical trials have yielded many innovative and promising treatments for pernicious genetic disorders but industry has shown slow development and dashed...
Quality & Compliance
A Guide to Solving Complex Life Sciences Challenges
Life sciences organizations are consistently inundated with decisions and challenges of varying scale. These can occur anywhere during the life sciences value chain, under any treatment modality...
Quality & Compliance
How to Decentralize Cell and Gene Therapy Treatments
The Challenge: CAGT Treatments Require Time and Lack Availability Persons diagnosed with life threatening diseases which are now treatable with cell and gene therapies (CAGT) often needed to wait for...