Regulatory Affairs

At 3D-PharmXchange, we provide comprehensive regulatory affairs expertise to help you navigate the complex regulatory landscape throughout your drug development journey. Our team supports every stage, from early development to post-approval, ensuring your program complies with all relevant regulatory requirements. We specialize in devising strategic regulatory plans that align with your development goals drafting, interactions with the regulators (national bodies, EMA or FDA) such as scientific advice, orphan drug designations and pediatric investigation plans but also includes preparation of clinical trial applications and marketing authorisation applications. By partnering with us, you benefit from our deep knowledge of global regulatory frameworks and our ability to guide you smoothly through the approval process.