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Regulatory

64 Articles available
FDA

Collaborations within FDA Intended to Improve Facility Inspections and Facilitate Drug Approvals

PAO-M09-17-NI-010
FDA

FDA’s Gottlieb Weighs in on the Drug Quality and Security Act (DQSA)

PAO-M06-17-NI-018
Regulatory

Implications of Serialization for the U.S. Pharma Industry

PAP-Q2-17-CL-001
Regulation

Serialization: The First Steps In Sales Unit Traceability and Data Management

PAP-Q2-17-CL-002
CDMO

Supporting the Tech Transfer Continuum for Cell & Gene Therapies

PAP-Q2-17-CL-003
Regulatory

Moving Quality to the Forefront Brings Measurable Results

PAP-Q2-17-CL-008
Regulatory

The Mission of Commissioning Agents, Inc.

RJ Filannino, Manager of Technical Services, Mid-Atlantic, Commisioning Agents Inc. (CAI)

PTV-M03-17-IN-004
Clinical Trials

Advancing Clinical Trial Efficiency with Electronic Informed Consent

APR-M03-17-NI-001
API

Anticipating Future Guidelines By Utilizing The Latest Technologies In Particle Characterization

POP-M03-17-NI-001
CRO

What’s New in Bioanalysis?

Chad Briscoe, Executive Director, PRA Health Sciences

PTV-M11-16-AP-019
Manufacturing

Continuous Processing

Stephen Sirabian, Executive Vice President, E/E Division, Glatt Air Techniques

PTV-M01-17-NS-002
Regulatory

FDA Issues Warning to Two More Companies

PAO-M03-17-NI-013
Regulatory

FDA, EMA Complete Mutual Recognition Journey

PAO-M03-17-NI-006
Equipment

Advancing Solid Dose Processing Efficiency and Effectiveness

PAP-Q1-17-CL-008
API

Experience and Expertise Facilitate Controlled Substance Manufacturing

PAP-Q1-17-CL-004
Clinical Trials

AAPS Expedited Pathways

PAO-M11-16-NI-002
Biologics

INNOVATION: Creating Solutions for Healthcare’s Ambitious Agenda

PAP-Q04-16-FA-001
CDMO

Q: What is Your Perception of the State of Serialization in Your Sector of the Pharma Industry?

PAP-Q04-16-RT-003
Supply Chain

Perspectives on Product Pricing Strategy and Practice

PAP-Q04-16-NC-001
Clinical Trials

Speed-to-Market: Process and Capacity on Demand

PAP-Q04-16-CL-014
CDMO

Achieving Successful Treatment Outcomes Through the Delivery of Manufacturing Services

PAP-Q04-16-CL-012
CDMO

Rx-360: An Industry Group Like No Other

PAP-Q04-16-CL-007
Outsourcing

Shaping the Conversation – Bringing Voice & Value

PAP-Q04-16-ED-001
API

Process Performance Qualification Prep: a Strategic Approach Leads to Success

PAP-Q03-16-CL-008
Aggregation

Track & Trace Systems for Serialization and Aggregation

PAP-Q03-16-CL-012
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