Compliance

Biologics, Proteins, Vaccines | Regulatory Affairs

What Will Change at FDA for 2021?

(R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?

Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21

Clinical Trials | Drug Development | QA/QC

RBQM Comes of Age: COVID as a Catalyst for Change

Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.

Online Exclusives Kristin Brooks, Managing Editor 04.01.21

Regulatory Affairs

Post-Pandemic Regulations

Envisioning clinical development regulatory practices in a post-pandemic world.

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 04.01.21

Enteris BioPharma: Custom Solutions – From Bench to Market

CDMO operations are housed within a 32,000-square-foot, FDA-inspected and cGMP-compliant facility in northern New Jersey.

Sponsored released by Enteris BioPharma 04.01.21

Breaking News | cGMP Manufacture | Industry News | Inspections

Metrics Contract Services Completes Russian Regulatory Inspection

Greenville, NC site approved to make an oncology drug to be marketed in Russia.

Tim Wright, Editor, Contract Pharma 03.09.21

Validation

Guide to Maintaining Validation of Older Facilities: Why, When and How

This guide explains some of the most common challenges found in aging facilities, tips for identifying when a facility requires revalidation and more.

Jubilant HollisterStier CMO

Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids.

Marcy Edwards, Marketing Manager 02.22.21

Biologics, Proteins, Vaccines | Regulatory Affairs

The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to “normalcy.”

Chad Landmon, Michelle Divelbiss and Alex Alfano, Attorneys - Axinn, Veltrop & Harkrider LLP 01.27.21

Breaking News | Drug Development | Industry News | Information Technology | Regulatory Affairs

Top BioPharma Form Accumulus Synergy

Aims to develop a cloud-based Global Data Sharing Platform to facilitate data and information sharing between industry and health authorities worldwide.

Kristin Brooks 01.22.21

Breaking News | Industry News | Information Technology | Validation

Global Biosciences Co. Selects ValGenesis VLMS

Will digitize the validation service activities for efficient and faster access to validated and safer products across 40 countries.

Contract Pharma Staff 01.20.21

Breaking News | Industry News | Information Technology | Validation

Gene Therapy Co. Selects ValGenesis' SaaS Platform

VLMS to digitize Its global validation programs.

Contract Pharma Staff 01.06.21

Drug Development | Industry News | Regulatory Affairs

The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".

Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21