Regulatory Affairs

cGMP Manufacture | Industry News | Regulatory Affairs

Recipharm Plans for Brexit

Establishes a dedicated taskforce to manage the potential impact on ops

05.24.18

Drug Development | Industry News | Promotions & Moves | Regulatory Affairs

Corbus Announces Key Hires

Dr. Robert Discordia will serve as VP, Pharmaceutical Development & Mfg, and Ross Lobell will serve as VP, Regulatory Affairs

05.22.18

Regulatory Affairs | Serialization

Serialization Readiness: A contract services provider perspective

The serialization challenge and why some contract service providers and brand owners are skeptical of each other's readiness

Online Exclusives Tim Wright, Editor 05.18.18

Regulatory Affairs

India raises bar for clinical trial oversight

New guidelines to bolster institutional ethical committees

S. Harachand, Contributing Editor 05.08.18

Regulatory Affairs

GDUFA II: Do You Have a Strategy?

Generic companies continue to face multiple challenges in an ever-increasing competitive market place

Janis A. Picurro, Lachman Consultants 05.08.18

Samsung BioLogics Achieves Regulatory Milestone

Becomes first in South Korean pharma industry to achieve ISO 22301 certificate

04.27.18

Emergent Completes Market Authorization

For BioThrax (Anthrax Vaccine Adsorbed) in five Concerned Member States (CMS) within the European Union (EU)

04.12.18

Regulatory Affairs

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle: ICH Q12

More than a decade after the birth of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) at a meeting in Brussels hosted by the European Federation of Pharmaceutical Industries and Associatio…

Sharif Ahmed, Lachman Consultants 04.10.18

Evotec Launches Drug Development Service

INDiGO has a proven track record of successfully reducing time and costs by more than 50%

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Mylan, Biocon Receive MAA

For their co-developed biosimilar insulin glargine, Semglee

03.28.18

Bio News | cGMP Manufacture | Collaborations & Alliances | Industry News | Regulatory Affairs

Nabriva, Roivant Enter License Agreement

To develop and commercialize lefamulin, for the treatment of community-acquired bacterial pneumonia, in greater China

03.27.18

Regulatory Affairs

Drug Safety Update

An uptick in adverse event reports doesn’t necessarily mean an increase in adverse events

Ben Locwin 03.12.18

Regulatory Affairs

OTC Drug Market Revenue to Exceed $178B by 2024

Growth driven by massive demand for health supplements and analgesics

Global Market Insights 03.09.18

Regulatory Affairs

From OMUFA To Opioids

CDMOs get involved in policy

Gil Roth, President, Pharma & Biopharma Outsourcing Association 03.09.18

Information Technology | Regulatory Affairs

FDA’s Increased Information Transparency

As a government entity, the U.S. Food and Drug Administration (FDA) has an obligation to provide transparency in its operations, which it does through its FDA Transparency Initiative.1 The goal is to enhance the understanding of stakeholders in FDA&r…

Ricki A. Chase, Lachman Consultants 03.09.18

Regulatory Affairs | Serialization

Ensuring Serialization Effectiveness

Taking on compliance, operational efficiency, and the actual benefits of serialization.

Justin Schroeder, Senior Executive Director, Global Marketing & Design, PCI Pharma Services 03.09.18

Regulatory Affairs | Serialization

Serialization as a Long-term, Not a Short-term, Solution

As serialization deadlines close in, flexible, hardware-agnostic solutions provide efficiency, speed and extra business value

William Minaeff, Senior Project Director, Adents 03.09.18

Bio News | Industry News | Promotions & Moves | Regulatory Affairs

Cognate Secures Capital Raise

The management buyout and capital raise will accelerate Cognate’s commercial activities for clients and prospects

02.23.18

PCI Hosts UK Government Visit

The visit was part of a trade mission to attract US businesses to invest in Wales and build on their commercial relationship

Videos

Bio News | Bioanalytical Services | cGMP Manufacture | Industry News | Regulatory Affairs

Vetter Receives Clean Manufacturing Award

The prize was awarded as part of the LOUNGES 2018, a trade event in the clean manufacturing sector

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Recipharm Plans for Brexit

Corbus Announces Key Hires

Serialization Readiness: A contract services provider perspective

India raises bar for clinical trial oversight

GDUFA II: Do You Have a Strategy?

Samsung BioLogics Achieves Regulatory Milestone

Emergent Completes Market Authorization

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle: ICH Q12

Evotec Launches Drug Development Service

Mylan, Biocon Receive MAA

Nabriva, Roivant Enter License Agreement

Drug Safety Update

OTC Drug Market Revenue to Exceed $178B by 2024

From OMUFA To Opioids

FDA’s Increased Information Transparency

Ensuring Serialization Effectiveness

Serialization as a Long-term, Not a Short-term, Solution

Cognate Secures Capital Raise

PCI Hosts UK Government Visit

Vetter Receives Clean Manufacturing Award

May 2018