Biological products, or biologics, are medical products derived from natural sources such as humans, animals, or microorganisms. These products, like traditional drugs, are often developed to treat diseases and medical conditions. Additionally, some biologics play a crucial role in preventing or diagnosing diseases.
At Transparon, we assist clients in preparing and filing dossiers for biological products, conducting gap assessments, and ensuring the successful submission of applications to regulatory authorities.
Examples of biological products include:
- Vaccine/r-DNA/Biosimilars
- Vaccines
- Blood and blood products for transfusion or further manufacturing
- Allergenic extracts used for diagnosis and treatment (e.g., allergy shots)
- Human cells and tissues used for transplantation (e.g., tendons, ligaments, and bone)
- Gene therapies
- Cellular therapies
- Tests to screen blood donors for infectious agents such as HIV
Let Transparon help you navigate the complex regulatory requirements and achieve successful product approval.
