Regulatory Affairs

Industry News | Promotions & Moves | Regulatory Affairs

Slayback Appoints Global Affairs SVP

Joan Janulis is also a noted speaker at various FDA/Industry conferences

07.17.18

Clinical Trials | Drug Development | Regulatory Affairs

Are EMA-Style Rules for First-in-Human Trials Coming to North America?

Insights from the 2018 DIA Global Meeting

Beatrice Setnik, Ph.D., Vice President, Scientific and Clinical Strategy, Early Phase, Syneos Health 07.03.18

Bio News | GMPs/GCPs | Industry News | Regulatory Affairs

MHRA Grants MeiraGTx Manufacturer’s Authorization

Enables the manufacture of gene therapy product candidates in current cGMP compliant facility

06.21.18

cGMP Manufacture | Industry News | Regulatory Affairs

Samsung BioLogics Licensed by Health Canada

To manufacture a monoclonal antibody drug substance at its first plant

06.21.18

WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo

Is first CDMO to support the approval of an innovative drug in China through the MAH pilot program

06.14.18

Regulatory Affairs | Solid Dosage/Creams/Ointments

Semi-Solid Dosage Forms

Compliance of semi-solid dosages to FDA Stage III Continuous Process Verification

José L. Toro, Ph.D., Lachman Consultants 06.12.18

Inspections | Regulatory Affairs

PAI Readiness – A Journey, not an Event

A look at what you need to do to get ready for a pre-approval inspection

Dr. Walter Matzmorr, Tunnell Consulting 06.12.18

QA/QC | Regulatory Affairs

The Outsourcing Balancing Act

Achieving the best blend of oversight and involvement

Leona Fitzgerald and Denise Moody, PPD 06.12.18

Bio News | cGMP Manufacture | Industry News | Regulatory Affairs | Risk Management

Stellar Announces Positive Third-Party Trial Results

The company's KLH manufacturing methods have achieved robust viral clearance

05.29.18

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