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Big Pharma Ramps up Expansion to Emerging Markets
How to Utilize FSPs for Better Outcomes
Breaking Barriers: Strategic Use of FSP Models to Expand Trials into Non-Footprint Countries
Exploring Oligonucleotide Drugs: An Overview of Pharmacokinetic & Bioanalytical Strategies
Indian Pharmaceutical Industry at a Crossroads
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Evotec and X-Chem Enter Collaboration Agreement
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Vetter's Rankweil Site Completes First 100 Aseptic Fills
NImmnune, BioTherapeutics Enter Research Collaboration
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Evotec and X-Chem Enter Collaboration Agreement
APL and CurifyLabs Partner for 3D-Printed Medicines
Vetter's Rankweil Site Completes First 100 Aseptic Fills
Lonza Completes Microbial Manufacturing Expansion in Visp
Sonoma Biotherapeutics Receives $45M Regeneron Milestone
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Pharma Matters Q&A: Alfasigma
A Molecule’s Journey: Break Down Roadblocks to Commercial Manufacturing Success
Tanvex BioPharma USA Achieves Dual U.S. Regulatory Milestones
Impurities in APIs and Their Effects on Products
Pace Life Sciences Completes Successful FDA Inspection of Operations in Oakdale, MN
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Filtration & Purification
GMPs/GCPs
Inspections
QA/QC
Regulatory Affairs
Validation
cGMP Manufacture
|
Drug Development
|
GMPs/GCPs
|
Parenterals
|
Regulatory Affairs
|
Solid Dosage/Creams/Ointments
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
Biologics, Proteins, Vaccines
|
cGMP Manufacture
|
GMPs/GCPs
|
Regulatory Affairs
|
Scale-up/Technology Transfer
|
Validation
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
Breaking News
|
Facilities
|
Industry News
|
Inspections
|
Regulatory Affairs
|
Validation
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
Regulatory Affairs: Quality By Design for Your Training Program?
Insights from the regulatory experts at Lachman Consultants.
Paul Mason, Executive Director, Lachman Consultants
06.12.24
Analytical Services
|
Laboratory Testing
|
QA/QC
|
Regulatory Affairs
How QMS Impacts Quality Maturity
Join us on July 18 for an interactive session with Susan Schniepp exploring various strategies behind quality maturity.
Sponsored
released by
Nelson Laboratories, LLC
06.03.24
Regulatory Affairs
Regulatory Affairs: Drug Shortages – No Solution in Sight!
Insights from the regulatory experts at Lachman Consultants.
Bob Pollock, Lachman Consultant Services, Inc.
05.24.24
Inspections
|
Regulatory Affairs
Regulatory Affairs: A Common Warning Letter Citation Explored
Insights from the regulatory experts at Lachman Consultants.
Tony Polletta, Lachman Consultants
05.17.24
Information Technology
|
Regulatory Affairs
The Future of Pharmacovigilance is Proactive
Data and AI can unlock the path to proactivity.
Bruce Palsulich, Vice President of Safety, Oracle Life Sciences
05.13.24
Aseptic Processing
|
Facilities
|
Fill/Finish
|
Injectables
|
Parenterals
|
Regulatory Affairs
Parenteral Perspectives
Exploring innovations, challenges, and future horizons in parenteral drug delivery.
Tim Wright, Editor, Contract Pharma
05.13.24
Information Technology
|
Regulatory Affairs
"3 Key Trends" with Rob Feltz
Sharp Services’ Director of Analytical and Formulation Services offers his thought leadership.
Online Exclusives
Contract Pharma
05.01.24
Regulatory Affairs
|
Serialization
|
Supply Chain
Anti-Counterfeiting Technology
How track and trace, serialization, and secondary packaging are defining the future.
Ben Locwin, Contributing Editor
04.10.24
QA/QC
|
Regulatory Affairs
Do You Know Your Product's Impurity Profile?
Regulatory insights from the experts at Lachman Consultants.
Paul Mason, Executive Director, Lachman Consultants
04.10.24
Biosimilars
|
Regulatory Affairs
Inflation Reduction Act and the Impact on Biosimilars
Exploring the IRA’s provisions and their impact to biosimilars.
Dinakaran (Dina) Balasubramanian, Dr. Reddy's Laboratories
04.10.24
Analytical Services
|
Methods Development
|
QA/QC
|
Regulatory Affairs
Regulatory Affairs: What is the New FDA Guidance on Q14 Analytical Procedure Development?
Insights from the experts at Lachman Consultants.
Joseph Posada, Consultant, Lachman Consultants
04.05.24
Clinical Trials
|
Drug Development
|
Regulatory Affairs
The High Five: Key Regulatory Topics for Drug Development in 2024
Master protocols in clinical trial design, patient outcomes in oncology, advancements of new modalities, use of AI/ML and digitizing clinical trials.
Patrick Brady, PharmD, Global Head, Therapeutic Innovation & Regulatory Science, IQVIA
03.18.24
Regulatory Affairs
The “Hows” of Drug Shortages
How bad does the problem need to become for Congress to act?
Martin Shimer, Executive Director, Lachman Consultants
03.15.24
Breaking News
Evotec and X-Chem Enter Collaboration Agreement
APL and CurifyLabs Partner for 3D-Printed Medicines
Pfizer Appoints Elif Aral as Regional President for Middle East, Russia, and Africa
Vetter's Rankweil Site Completes First 100 Aseptic Fills
NImmnune, BioTherapeutics Enter Research Collaboration
View Breaking News >
CURRENT ISSUE
July/August 2024
Big Pharma Ramps up Expansion to Emerging Markets
How to Utilize FSPs for Better Outcomes
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