Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Compliance Research Regulation 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies.

Engineer 52

Engineer Genetics Clinical Research Research 52

FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them. Dextrum Laboratories Inc.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

Delveinsight

SEPTEMBER 8, 2021

Pharma Consultants come up with various business strategies, technical or non-technical, management of quality control & testing, identifying relevant supplies and equipment, drug – design & development, and regulation of clinical trials. Pharma Consultancy Modus Operandi. Market Assessment & Operational Sales.

Marketing 52

Marketing Production Sales Life Science 52

Pharmacy Checkers

DECEMBER 12, 2019

A majority of inspections resulted in findings of non-compliance. In fact, they have the exact same problems as we do in ensuring that the active pharmaceutical ingredients (APIs) used to make our drugs are of the highest quality and without contaminants. -based inspectors who go overseas, 66 remained unfilled. Both the EU and the U.S.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

Pharmaceutical Technology

APRIL 27, 2023

mRNA-based drug trials in overdrive The number of clinical trials for infectious diseases has ramped up in recent years—fuelled by the pandemic but now investigating treatments for seasonal influenza strains, respiratory viruses as well as HIV and Hepatitis B and C.

Manufacturing 130

Manufacturing RNA Contamination Vaccination 130