This section is dedicated to more general regulatory affairs information, available for any regulatory affairs professional to consult, or for other stakeholder to get a first picture on what regulatory affairs are and how to approach the regulatory aspects of the commercialization of a pharma product in a new country.
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- Regulatory Affairs in Emerging Markets
- Fundamentals of Regulatory Affairs
- ANMAT: the Argentinean Health Authority
- Drug registration in Argentina
- Registration of biological drug products in Argentina
- First batch verification
- Drug product certificate renewal in Argentina
- Orphan drug regulation
- GMP inspections: regulatory aspects
- Central America
- Get in touch!