Search results for " regulatory"

Article Regulatory Challenges in the QbD Paradigm
With the dawn of the 21st century came the realization that changes must be made by both the pharmaceutical industry and regulatory authorities across the globe. These changes are necessitated by a pl…

Article Regulatory Requirements for Safe and Efficient Biologic Drug Development
Topics covered include: 1:33 – Key regulatory guidelines for biopharma companies to follow 3:00 - Recent guidance changes/additions that impact biopharma 3:37 - Areas where additiona…

Article Getting Your Investigational Drug Regulatory Ready
This article outlines basic strategies for efficient regulatory review and drug approval.

Resource Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom's government agency  responsible for ensuring that medicines and medical devices work, and are acceptably safe. T…

Article Developing a New Biologic Drug: Regulatory Challenges and Considerations
Click here to learn more >> Key milestones and planning ahead for compliance when bringing a new biologic drug to market

Regulatory/QbD

Article A Look Ahead at BioPharma Manufacturing and Regulation
The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use in assessing the safety, effectiveness, quality, and performance of products.…

Article Quality by design for biotechnology products—part 1
…e and establishing the process control strategy; to later stages, including incorporating QbD into a regulatory filing and facilitating efficient commercial processes and manufacturing change flexibi…

Article Efforts Accelerate to Streamline Postapproval Change Process
…mprove products and systems and ensure reliable supply of high-quality drugs and biologics that meet regulatory standards. With more breakthrough and critical therapies gaining fast approval based on…

Article Early Communication with Regulators is Essential for SMEs
Europe’s regulatory agencies have been stepping up their support for small- and medium-sized enterprises (SMEs), including micro companies, in an effort to stimulate more development of innovative med…

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