Regulatory Submission
Regulatory Submission is the formal process of compiling and submitting evidence packages to regulatory agencies — FDA, EMA, EASA, NMPA, MDCG, and others — in order to obtain permission to market, use, or operate a product. In medical devices, pharmaceuticals, aerospace, and automotive type-approval, the submission is a gating activity tied to release.
Scope
The process spans regulatory strategy, predicate or comparator selection, evidence compilation (design dossier, risk file, clinical or test data), submission authoring (510(k), PMA, IDE, MDR Technical Documentation, NDA, EU Type Approval), agency Q&A management, and post-approval reporting obligations. PLM systems serve as the controlled source of truth for the design and verification artifacts that the submission references.
Relationships (see sidebar)
- Realizes Regulatory Compliance and Product Quality.
- Supported by logical capabilities such as ALM Traceability, the Requirements Traceability Matrix, and the Document Vault.
- Tightly coupled with Quality Management and Release Management.
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