Key requirements to enter Central America

The Central American pharmaceutical market represents a great opportunity for laboratories from Latin America, Asia, and Europe. But entering successfully requires meeting certain technical and strategic requirements.

1. International certifications

Having registrations and endorsements from organizations such as:

• FDA (USA)

• EMA (Europe)

• INVIMA (Colombia)

• COFEPRIS (Mexico)
  is an added value in bidding and health registration processes.

2. Dissolution and bioequivalence studies

Especially for products used continuously (antihypertensives, antibiotics, antiretrovirals), having these studies ensures trust and acceptance by authorities and physicians.

3. Adaptation to local regulations

Each country requires specific technical documentation, labeling validations, and internal processes such as stability testing and storage conditions.

4. Reliable logistics network

Good local representation ensures products arrive on time, properly, and under the necessary conditions. FG Pharma's experience guarantees compliance and traceability.

🤝 At FG Pharma we offer:

✔ Market evaluation
✔ Technical advisory for registration
✔ Legal representation before the DNM
✔ Institutional and private distribution

Is your laboratory ready to take the next step?
🔎 We'll guide you through the process. Write to us at contacto@fgpharmasv.com