Regulatory Affairs

cGMP Manufacture | R&D | Regulatory Affairs

Sustainability in Pharma: CDMOs Move Fast to Cut Carbon Footprint

Massive overhaul in works to embed greener processes.

S. Harachand, Contributing Writer, Contract Pharma 10.01.24

25th Anniversary Retrospective

Contract Pharma provides a brief look at some key industry topics and changes over the years, what it looked like then and where it is today.

Kristin Brooks, Managing Editor 10.01.24

Regulatory Affairs | Supply Chain

Securing Sustainability Throughout the Pharmaceutical Supply Chain

Engagement is the key to addressing Scope 3.

Davuluri Sucheth Rao, Vice Chairman and CEO, Neuland Labs 10.01.24

Aseptic Processing | Fill/Finish | Parenterals | Regulatory Affairs

Pioneering Production Cell for the Pharmaceutical and Biotech Industry

Vetter and Syntegon join forces to develop Versynta microBatch.

Dr. Laura Moody, Director of Product Management Pharma North America, Syntegon 10.01.24

Information Technology | Regulatory Affairs

Automated Submission Generation: The Next Frontier for Regulatory GenAI?

With some powerful generative AI regulatory use cases now emerging at pace, it’s only a matter of time before the technology will be driving automated submissio

Tim Wright, Editor 10.01.24

Regulatory Affairs

FDA Clinical Trial Diversity Action Plan Guidance – What Does it Mean?

Exploring the FDA’s new guidelines to enhance diversity in clinical trials and their impact on the pharmaceutical industry.

Susan Shorter, Senior Quality, Risk and Regulatory Compliance Specialist, Greenphire 10.01.24

Regulatory Affairs

New Risks Discovered as U.S. and EU Drug Shortage Efforts Start to Merge

Navigating emerging threats of drug shortages in the U.S. and EU.

Patrick Day, Lachman Consultants 10.01.24

Clinical Trials | Regulatory Affairs

FDA sIRB Mandate: A Chance to Reassess Site Performance

Characteristics of top performing sites.

James Riddle, Senior Vice President, Global Review Operations, Advarra 09.23.24

Breaking News | Industry News | Regulatory Affairs

U.S. House of Representatives Passes the BIOSECURE Act

Bill would prohibit contracting with certain Chinese biotechnology companies deemed potential national security risks.

09.13.24

Biologics, Proteins, Vaccines | cGMP Manufacture | Regulatory Affairs

Post-COVID Trends in Biopharma Contract Manufacturing

Industry is shifting back to previous long-term growth trends.

Ioanna Deni, Research Scientist and Market Researcher, BioPlan Associates 09.05.24

Pharma Matters Q&A: Alfasigma

A Q&A with Rocco Paracchini, director of Alfasigma’s CDMO business unit, about trends in the Italian CDMO market.

Sponsored released by Alfasigma 09.04.24

A Molecule’s Journey: Break Down Roadblocks to Commercial Manufacturing Success

In this guidebook, experts share key considerations for biopharmaceutical companies as they advance their antibody drug to commercial manufacturing.

Sponsored released by MilliporeSigma 09.03.24

Biosimilars | Breaking News | Industry News | Regulatory Affairs

Tanvex BioPharma USA Achieves Dual U.S. Regulatory Milestones

FDA approves Nypozi and grants BLA acceptance of TX-05.

08.30.24

Upperton Pharma Gains MHRA Approval at Nottingham Facility

The facility gives the green light to support clients from formulation development to late-phase clinical manufacture and product registration.

07.18.24

Analytical Services | Bioanalytical Services | Laboratory Testing | QA/QC | Regulatory Affairs

The Importance of Change Control within the Laboratory Setting

Exploring best practices for the employment of quality risk management within laboratory operations.

Paul Mason , Executive Director, Lachman Consultant Services, Inc. 06.19.24

Regulatory Affairs

Barriers to Parallel Scientific Advice Hurdles May Be Too High!

Insights from the regulatory experts at Lachman Consultants.

Bob Pollock, Lachman Consultant Services, Inc. 06.18.24

Clinical Trial Materials | Clinical Trials | Drug Development | Regulatory Affairs

Integrated Clinical Development & Supply: Breaking Down the Early Dev Journey of a Small Molecule

Along with a discussion, examples of real-life tactical and operational decisions involved in the integrated approach to drug development will be presented.

Sponsored released by Catalent Pharma Solutions 06.13.24

QA/QC | Regulatory Affairs