Following the recent announcement of our expanded post-market surveillance services at LAMA, we’re now taking a closer look at one of the most critical components of that offering: pharmacovigilance.
While post-market surveillance covers a wide range of activities, pharmacovigilance deserves particular attention—especially for companies operating across Latin America, where regulatory expectations are becoming more rigorous and clearly defined.
What Is Pharmacovigilance?
Pharmacovigilance is the process of monitoring and evaluating the safety of health products once they’re on the market. Its primary goal is to detect, assess, and prevent adverse effects or other safety concerns that may arise during real-world use.
In simpler terms, it’s about making sure that your product continues to be safe and effective over time, especially as it reaches larger, more diverse patient populations and is used under varying conditions.
Why It’s Essential:
For companies placing medicines or medical products on the market, pharmacovigilance is more than just a regulatory requirement—it’s a public health responsibility. Authorities across Latin America are placing growing emphasis on continuous safety monitoring, with clearer expectations around adverse event reporting, local representation, and transparent communication.
That’s why it’s so important not only to have systems in place, but to work with partners who understand the local nuances and regulatory obligations across the region.
In recent conversations with clients about our post-market offerings, one question has come up more than once:
“Our product is safe—why would we need pharmacovigilance?”
It’s a fair question, and one we understand. But the reality is that safety doesn’t end at the point of approval. Once a product is in real-world use, it’s exposed to new variables—broader populations, longer durations, and unforeseen conditions that clinical trials may not fully capture.
Pharmacovigilance ensures we stay alert, respond promptly, and document findings in a structured, compliant way.
It’s not just about anticipating problems, but about being prepared if and when something happens.
Think of it like riding a motorcycle: even the best rider wears a helmet. Not because they expect to crash—but because they recognize the importance of protection, and because helmet laws apply regardless of your confidence or skill level. Pharmacovigilance works the same way. It’s not a reflection of doubt in your product—it’s a sign of your commitment to compliance, safety, and long-term success. And just as helmet laws vary by country, so too do pharmacovigilance requirements across Latin America.
That’s where LAMA comes in.
Local Knowledge, Regional Insight
As with all our services, LAMA’s pharmacovigilance support is built on a foundation of local expertise and regional coordination. We understand the differences between regulatory frameworks and expectations in each market, and we tailor our approach to offer country-specific solutions backed by regional oversight.
In the coming weeks, we’ll continue to explore this topic further—sharing updates, regulatory changes, and practical insights to help you meet your obligations and operate with confidence in the region.
As always, our goal is to keep you informed, prepared, and one step ahead.
