What is the difference between regulatory affairs and quality assurance?What is the role of Regulatory Affairs in drug development?
| Feature | Regulatory Affairs | Quality Assurance |
| Focus | Legal compliance and market access | Product quality and consistency |
| Scope | Entire product lifecycle, with an emphasis on regulatory requirements | Entire product lifecycle, with an emphasis on quality standards |
| Primary Goal | Ensuring products can be legally sold | Ensuring products are of high quality |
| External vs. Internal | Primarily interacts with external regulatory bodies | Primarily interacts with internal teams and external auditors, focusing on internal processes and systems |
| Documentation | Regulatory documents (e.g., NDAs, PMAs, 510(k)s) | Quality-related documentation (e.g., testing protocols, CAPA reports) |
Regulatory Affairs professionals ensure drugs comply with legal and safety standards throughout the development process, from initial research to post-marketing surveillance, acting as a crucial bridge between pharmaceutical companies and regulatory agencies.
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