Workflow Capabilities for Better Planning, Management, and Reporting
Regulatory Affairs is responsible for developing and implementing strategies that ensure newly developed drugs will surpass regulatory requirements for world-wide commercialization. In this role, Regulatory Affairs is the primary communication link between the drug-developer company and agencies such as the US Food and Drug Administration (FDA) and its international counterparts.
A key deliverable in the drug approval process is the filing of Chemistry, Manufacturing and Controls (CMC) regulatory dossiers with regulatory agencies. QbD has now become a central element in CMC regulatory dossiers. As a result, CMC Project Management is empowered to lead drug development projects from the start of Investigational New Drug (IND) preparation to New Drug Application (NDA) approval and launch. CMC Project Management teams are typically comprised of cross-functional representation including Regulatory/Quality, CMC Project management, Pharmaceutical Development, Clinical Development and Commercial.
Inference for QbD, especially the content management and workflow capabilities of Inference Repository, enables Regulatory Affairs and CMC Project Management to:
- Manage drug development project activities to meet the requirements of the project team including achieving project timelines and goals. These projects may encompass API synthesis development, formulation development, analytical development, clinical packaging and labeling and regulatory affairs activities, such as submission drafting and review.
- Maintain systems for filing, retrieving and managing regulatory documents, technical documents, internal, CMC SOPs, and any other QbD documents as necessary.
- Assist in the creation, tracking and management of project budgets, timelines, tasks, responsibilities and QbD activities.
- Participate in cross-functional and multi-supplier teams; and assist in the development of project plans, reports and other project documentation.
- Find and access up-to-date QbD information needed to prepare written technical meeting summaries and reports.
- Draft, review and manage SOPs and other QbD procedures.