Navigating Pharmacovigilance Requirements in LATAM

When do biotech companies and startups need pharmacovigilance? Many assume it begins after approval. This is understandable because, with limited resources, the focus remains on science, funding, clinical milestones, and product development.  But in reality, clinical...

Clinical safety management becomes essential for biotech companies earlier than many anticipate. Regulators require clear safety oversight, structured reporting, and reliable adverse event management even in early development. However, most companies at this stage...

Clinical trial safety management is essential across the drug development lifecycle. From first-in-human studies to late-phase development and post-marketing commitments, companies need a clear system for identifying, assessing, documenting, and acting on safety...