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Implementing an Automated DOE in Twin Screw Wet Granulation
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SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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Filtration & Purification
GMPs/GCPs
Inspections
QA/QC
Regulatory Affairs
Validation
Clinical Trials
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Drug Development
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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
Aseptic Processing
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Facilities
|
Fill/Finish
|
Information Technology
|
Injectables
|
Parenterals
|
Regulatory Affairs
|
Supply Chain
The Road Ahead for CDMOs in 2024
Whether it’s an imminent supply chain reckoning, or a raft of new modalities, excellent opportunities still abound for the “right” CDMOs.
Gil Roth, Pharma & Biopharma Outsourcing Association (PBOA)
03.11.24
Biosimilars
|
Regulatory Affairs
Regulatory Affairs: The Generic Industry Faces External Challenges
Insights from the regulatory experts at Lachman Consultants.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
03.04.24
Regulatory Affairs
Regulatory Affairs: The Eyes Have It!
Insights from the regulatory experts at Lachman Consultants.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
02.23.24
Regulatory Affairs
Regulatory Affairs: Canada Responds to Florida’s Import Plan
Canada springs into action after FDA approves Florida’s plan to import drugs from our neighbors in the North.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
02.08.24
Inspections
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QA/QC
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Regulatory Affairs
Regulatory Affairs: FDA’s Office of Compliance Issues FY 2023 Annual Report
Issued 170 warning letters and monitored 264 drug recall events during the year.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
02.01.24
Analytical Services
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Bioanalytical Services
|
Laboratory Testing
|
QA/QC
|
Regulatory Affairs
Stability Testing for Drug Products: Ensuring Safety, Efficacy & Regulatory Compliance
Evaluating extractables and leachables, overseeing manufacturing processes, ensuring adherence to CGMPs and comprehensive packaging testing.
Sandi Schaible and Britt Jones, WuXi AppTec
02.01.24
Biologics, Proteins, Vaccines
|
Drug Development
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Regulatory Affairs
2023: The Year of Re-alignment, Yet All Data Points to Green Shoots Ahead for 2024
An in-depth analysis of the health of the CRO/CDMO sector.
Brian Scanlan, Operating Partner - Life Sciences, Edgewater Capital Partners
02.01.24
Inspections
|
Regulatory Affairs
FDA Inspections & Compliance Trends
A look back at 2023 and what 2024 will bring.
Online Exclusives
Ben Locwin , Contributing Writer
01.26.24
Information Technology
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Regulatory Affairs
Regulatory Affairs: Cross-Agency Cooperation Takes Next Step in AI Maturity
A blog exploring the regulatory issues impacting the pharma industry with the experts at Lachman Consultants.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
01.19.24
Regulatory Affairs
Regulatory Affairs: Florida the First State to Receive FDA’s Authorization for Canadian Drug Import Program
How will Canada react if the importing of drugs from the U.S. winds up causing shortages of the imported products in Canada?
01.12.24
Breaking News
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Clinical Trials
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CRO News
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Drug Development
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Regulatory Affairs
Odyssey Health Selects Syneos to Support Concussion Treatment Trial
Will provide a regulatory review for the clinical development plans for Odyssey's concussion drug ONP-002 and novel intranasal device.
11.16.23
Information Technology
|
Regulatory Affairs
FDA Watch: Artificial Intelligence
Cross-agency cooperation takes next step in artificial intelligence maturity.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
11.09.23
QA/QC
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Regulatory Affairs
How Mature is Your Quality Management Program?
Technology is key in driving quality improvement.
Paul Mason, Ph.D., Senior Director, Lachman Consultants
11.02.23
APIs
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Clinical Trial Materials
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Process Validation
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QA/QC
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Regulatory Affairs
Regis Custom Pharma
...
Deanna Rentner, Marketing Coordinator
10.26.23
Drug Development
|
Regulatory Affairs
Challenges and Opportunities of the Health Technology Assessment Regulation
Deciphering EU HTA legislation ahead of the 2025 implementation deadline.
Anke van Engen and Edel Falla, IQVIA
10.23.23
Analytical Services
|
Bioanalytical Services
|
Biologics, Proteins, Vaccines
|
Regulatory Affairs
"3 Key Trends" with Kai Lipinski
ReciBioPharm’s Chief Scientific Officer offers his thought leadership.
Online Exclusives
10.20.23
QA/QC
|
Regulatory Affairs
Quality Management Paradigm Shift: Risk-Centric Practices Come Center Stage
Data-driven, pro-innovation strategies advance new-era therapies.
Soman Harachand, Contributing Writer
10.17.23
Regulatory Affairs
Signs of Progress on the Nitrosamine Front
Notes from the Nitrosamines Session at GRx+Biosims 2023.
Jennifer Leaming, Principal Consultant, Lachman Consultants
10.13.23
Breaking News
Parexel Announces CEO Transition
DifGen Acquires FDA-Registered Manufacturing Facility
Quotient Sciences Makes Executive Leadership Team Appointments
Plenaries Discuss AI and Next-Gen Modality Development at AAPS NBC
SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
View Breaking News >
CURRENT ISSUE
March 2024
Implementing an Automated DOE in Twin Screw Wet Granulation
Sustainable Pharmaceutical Packaging
Pre-filled Syringe Packaging Trends
Liquid Pharmaceutical Filling: Small, Smaller, Micro Batches
Newsmakers Q&A: BioVectra
Multi-particulate Formulations – Tablets or Capsules?
Manufacturing Equipment Trends
OSD Outsourcing: Savvy CMOs Hone Skills as Complex APIs Fuel Demand
Catalent Acquisition by Novo Holdings: Evolution of the Industry(?)
The Road Ahead for CDMOs in 2024
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