Regulatory Affairs
Advanced Degrees
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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
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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
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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
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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
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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
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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
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Aseptic Processing | 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
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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
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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
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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
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Inspections | QA/QC | 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
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Analytical Services | 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
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Biologics, Proteins, Vaccines | Drug Development | 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
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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
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Information Technology | 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
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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
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Breaking News | Clinical Trials | CRO News | Drug Development | 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
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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
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QA/QC | 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
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APIs | Clinical Trial Materials | Process Validation | QA/QC | Regulatory Affairs
