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131 Articles Available
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PLIs
A Strategic Approach to Pre-License Inspections
PAO-11-022-CL-03
Lipid Excipients
Regulatory Considerations for Lipid Excipients
PAO-07-022-CL-04
Column: Regulatory Spotlight
The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative
PAO-06-022--NI-05
Column: Supply Chain
Creating a More Resilient Pharmaceutical Supply Chain One Segment at a Time
PAO-06-022--NI-09
Data Management System
Generis Celebrates New Milestones as Swathes of the Global Pharma Industry Default to CARA Life Sciences™ to Manage Critical Data and Content
PR-M06-22-06
Regulatory Data
Data-Based Regulatory Submissions: What DADI Means for You
PAO-05-022-CL-08
Column: Regulatory Spotlight
New FDA Guidance on Real World Evidence/Real World Data
PAO-03-022-NI-03
Oncolytic Viruses
Best Practices For Oncolytic Virus Design, Development, and Manufacturing
PAO-02-022-CL-17
Regulatory
FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review
PR-M03-22-03
Leadership Appointment
Generis Appoints Head of Life Sciences as CARA™ Growth Soars
PR-M01-22-20
Clinical Supply
Integrating a Personal Approach to Clinical Supply Services
PAO-09-21-CL-08
Cell and Gene Therapy
Quality and Regulatory Challenges Surrounding New Cell and Gene Therapy Products
PAO-09-21-CL-07
Live Biotherapeutic Products
Framing the Narrative on CMC Development for Microbiome Therapeutics
PAO-06-21-CL-05
Gene Therapy
Planning for Success, Addressing Quality Early for Gene Therapies
Digital Therapeutics
Digital Therapeutics: Redefining Prescription Medication in the Information Era
PAO-05-21-NI-01
Fill-Finish Services
Avara Liscate: High Standards and Expertise in Sterile Manufacturing
PAP-Q2-20-CL-005
COVID-19
Regulating Clinical Trials in Pandemic Times
PAP-Q2-20-NI-005
Partnership
Yseop and Litera Partner to Fast-Track Regulation Submission Processes for Life Sciences Companies
PR-M01-20-NI-011
Glocalization
From Regulatory Convergence to Global Regulatory Harmonization
PAP-Q3-19-NI-004
Manufacturing Technology
Q: How does your company manage to provide local services/support while still efficiently managing global compliance?
PAP-Q2-19-NI-006
Novel Therapies
Q: What do you identify as the greatest advances that have been achieved in recent years with respect to harmonization of pharmaceutical regulations?
PAP-Q2-19-NI-007
Regulatory
Are EMA and FDA Decisions Diverging?
PAO-M08-19-NI-037
Fecal Transplant
Fecal Transplant Associated with One Patient Death
PAO-M06-19-NI-020
Regulatory
Regulatory Spotlight: Following the Tobacco Road
PAP-Q2-2019-NI-005
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