Blogs
USA: FDA Confirms the Guidelines in t…
The US Food and Drug Administration (FDA) has finalised guideline to assist sponsors in the clinical …
Uncertainty as a Factor in Determinin…
With the recent announcement from FDA’s Center for Devices and Radiological Health (CDRH) about their…
Regulatory CMC Changes – Challe…
CHALLENGES:
Abiding by the national laws and regulations is a necessity for biopharma organi…
Regulatory Intelligence (RI) Unbolts …
Drug development has become highly complex than ever before since the globalization of the life scien…
Luxembourg and The Netherlands benefi…
Luxembourg and the Netherlands were added into the mutual recognition agreement between the European …
European Medicines Agency Seeks Publi…
European Medicines Agency has released a draft guideline on the quality requirements for medical devi…
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