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Regulatory

63 Articles available
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

Q: How is the Need to Provide Local Drug-Product Supply in Multiple Regions Around the World Impacting Pharmaceutical Manufacturing Facility and Equipment Design?

PAP-Q1-17-RT-002
API

Q: What will be the Impact of the Requirements that Drug Manufacturers Gain a Similar Level of Supply Chain Understanding for Excipients as they Must Have for APIs?

PAP-Q1-17-RT-005
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

Q: What Are You Doing to Become a Premier Outsourcing Partner in the Context of FDA’s Recent Shift to a Focus on Quality Culture Rather than Just Metrics?

PAP-Q04-16-RT-002
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
Excipients

What Are the Latest Guidelines for Excipients?

POP-M07-16-NI-001
EDC

The Pharmaceuticals App Market is Comparatively Weak and Inherently Limited, but Considerable Potential Exists

APR-M07-16-NI-001
CDMO

Customer Experience: Key to Growth in the Outsourced Services Industry

PAP-Q1-16-IC-001
API

Continuous Processing: Meeting the Need for New Manufacturing Strategies

PAP-Q1-16-CL-005
CDMO

Will Biosimilars Make a Difference for the CMO/CDMO Market?

POP-M11-15-NI-001
API

What Does It Mean to be a Full-Service CDMO?

PAP-Q4-15-CL-002
API

In-depth Process and Product Expertise – This is Key to CDMO Support of Orphan Drug and Breakthrough Therapy Development & Commercialization

PAP-Q4-15-CL-004
Formulation

Choosing the Optimal Drug Delivery System to Meet Patient Needs

PAP-Q4-15-CL-008
API

Challenges Facing Pharmaceutical Excipients

APR-M05-15-NI-001
Clinical Trials

How a CMO Can Help With Investigational New Drug Applications

PAP-APR-S01-CL-002
Excipients

Speaking the Same Language – The Gap Between the Sales Pitch and Supplier Selection Criteria – And How It Applies in the Excipients Market

APR-M03-15-NI-004
Outsourcing

Biopharmaceutical Outsourcing To CROs In Emerging Markets Surges For 2015

LSL-M03-15-NI-002
Outsourcing

Selecting An Outsourcing Partner For Vaccine Production

ICO-M03-15-NI-001
CDMO

What Does 2015 Hold For The Indian CMO Industry?

LSL-M03-15-NI-003
Biologics

Logistics Providers Strive to Fulfill Biopharma Needs – Specialty Companies Offer Advantages, but Get a Bad Rap on Price

LSL-M11-14-NI-002
Outsourcing

Sponsors Not the Only Party to Benefit from Clinical Trials in Emerging Markets

POP-M06-14-NI-001
Biologics

Pre-filled Syringe Technology Benefits Patients, Healthcare Providers and Drug Makers

CIO-M06-14-NI-001
Outsourcing

2014 Trends in Strategic Outsourcing — Changes in the Qualities that Drive Outsourcing Partner Selection

CIO-M01-14-NI-001
Outsourcing

What Can 2013 Outsourcing Trends Lead Us to Expect In 2014

LSL-M12-13-NI-001
Outsourcing

The Top CROs by Therapeutic Indication Share Strong Regulatory and Productivity Performance

LSL-M09-13-NI-001
Outsourcing

Outsourcing Clinical Research — Trends by Customer Group

LSL-M03-13-NI-001
Outsourcing

How Relevant are 483s in Terms of Compliance Perception?

CIO-M11-12-NI-001
Clinical Trials

Will A Focus On Innovation Pay Off For Custom Synthesis Providers?

CIO-M08-12-NI-001
Outsourcing

Capacity Issues and the Question: To Insource or Outsource?

LSL-M08-12-NI-001
Outsourcing

CROs & CMOs: Focusing On Innovation

LSL-M05-12-NI-001
CDMO

Process Optimization: Innovation's Role

PPO-M04-12-NI-001
Outsourcing

Outsourcing to Emerging Markets: The Effect of the European Economic Crisis

PTO-M02-12-NI-001
Outsourcing

Optimizing the Partner Selection Process for Drug Developers

LSL-M12-11-NI-002
Outsourcing

Who Should Be Doing Your Pharmaceutical Analytical Testing — a CRO or CMO?

PPO-M12-11-NI-001
Clinical Trials

Where Do Strategic Business Opportunities Lie For Mid-Tier CROs?

PCO-M10-11-NI-001
CMO

Sterile Manufacturing Opportunities

PPO-M10-11-NI-001
CMO

Contract Services Spending: Who's Spending What, and Where?

BIO-M10-11-NI-001
Clinical Trials

Benefit From Clinical Trials In Emerging Markets While Limiting Risk Exposure

LSL-M09-11-NI-001
CDMO

Customer Drivers Influencing Supplier Differentiation

PTO-M08-11-NI-001
Outsourcing

Do Companies That Offer Regulatory Support Services Score Higher On Regulatory Compliance?

LSL-M08-11-NI-001
CMO

Strong Regulatory Compliance and Reliability Indicative of Solid Partnership Choices

LSL-M06-11-NI-001
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