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.
Article
Getting your investigational drug regulatory ready
Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational journey. From the submission of an investigational new drug (IND) application, regulators…
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…
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Developing a New Biologic Drug: Regulatory Challenges and Considerations
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Key milestones and planning ahead for compliance when bringing a new biologic drug to market
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A Look Ahead at BioPharma Manufacturing and Regulation
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use …
Article
Quality by design for biotechnology products—part 1
… and establishing the process control strategy; to later stages, including incorporating QbD into a regulatory filing and facilitating efficient commercial processes and manufacturing change flexibil…
Article
Efforts Accelerate to Streamline Postapproval Change Process
…prove 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 …