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…

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…

Regulatory/QbD

Article Quality by design for biotechnology products—part 3
… 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 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 Bioterminology: A Guide to the Biopharmaceutical Lexicon
(See PAS)  CBE-30 Changes being effected within 30 days; a regulatory submission sent to FDA to request minor changes in a manufacturing process or its control. FDA has 30 days in which to respon…

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 …

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 Quality by design for biotechnology products—part 2
… 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 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…

Next Page