Biologics

Scientific breakthroughs have fueled a surge in the development of new biologics, or biopharmaceuticals. Quintiles has responded by forming a dedicated and highly experienced global biologics regulatory team.

Because we have in-depth experience with the differences between the regulatory requirements for traditional drugs and biologics, we can help you with strategic planning and regulatory submissions for your products.

Our group of seasoned strategists includes those who have previously worked at the FDA’s Center for Biologics Evaluation and Research (CBER) for many years or who have extensive experience working with the EMEA and other regulatory agencies. Together they offer an in-depth understanding of both the science and regulatory requirements for bringing new medicines to market.

• Regulatory and Medical Writing Services
• Electronic Submissions and eCTD
• Orphan Drugs
• Regulatory Solutions