Pharma's Almanac | Regulatory

135 Articles Available

1 6

Cell and Gene Therapy Regulatory

Navigating Regulatory Complexity for Cell and Gene Therapies

IND, NDA, and BLA

Building a Regulatory Roadmap for IND, NDA, and BLA

PAO-03-24-CL-10

Cultivated Meat

Leveraging Biopharma Sensor Technologies for Cultivated Meat Processes

PAO-05-23-CL-02

Clinical Trials

Early Reports of Positive Experiences with EMA’s New Clinical Trials Information System

PAO-02-23-CL-02

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

PAO-05-21-CL-02

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

1 6

Regulatory

135 Articles Available

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Cell and Gene Therapy Regulatory

Navigating Regulatory Complexity for Cell and Gene Therapies

IND, NDA, and BLA

Building a Regulatory Roadmap for IND, NDA, and BLA

Cultivated Meat

Leveraging Biopharma Sensor Technologies for Cultivated Meat Processes

Clinical Trials

Early Reports of Positive Experiences with EMA’s New Clinical Trials Information System

PLIs

A Strategic Approach to Pre-License Inspections

Lipid Excipients

Regulatory Considerations for Lipid Excipients

Column: Regulatory Spotlight

The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative

Column: Supply Chain

Creating a More Resilient Pharmaceutical Supply Chain One Segment at a Time

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

Regulatory Data

Data-Based Regulatory Submissions: What DADI Means for You

Column: Regulatory Spotlight

New FDA Guidance on Real World Evidence/Real World Data

Oncolytic Viruses

Best Practices For Oncolytic Virus Design, Development, and Manufacturing

Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

Leadership Appointment

Generis Appoints Head of Life Sciences as CARA™ Growth Soars

Clinical Supply

Integrating a Personal Approach to Clinical Supply Services

Cell and Gene Therapy

Quality and Regulatory Challenges Surrounding New Cell and Gene Therapy Products

Live Biotherapeutic Products

Framing the Narrative on CMC Development for Microbiome Therapeutics

Gene Therapy

Planning for Success, Addressing Quality Early for Gene Therapies

Digital Therapeutics

Digital Therapeutics: Redefining Prescription Medication in the Information Era

Fill-Finish Services

Avara Liscate: High Standards and Expertise in Sterile Manufacturing

COVID-19

Regulating Clinical Trials in Pandemic Times

Partnership

Yseop and Litera Partner to Fast-Track Regulation Submission Processes for Life Sciences Companies

Glocalization

From Regulatory Convergence to Global Regulatory Harmonization

Manufacturing Technology

Q: How does your company manage to provide local services/support while still efficiently managing global compliance?