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Cell, Tissue, and Gene Therapies

You create new products at the speed of innovation. And regulators race to keep pace. Commercial success and compliance can sometimes seem at odds.

The lawyers at Hogan Lovells uncover opportunity and mitigate risk for clients regarding cell, tissue, and gene therapies. From responding to U.S., EU, and Asian regulators, to marketing regenerative medicine, new stem cell, and advanced therapy developments. Many of us have served as regulators, and maintain relationships with FDA, EMA, and other agencies. So we are primed for shifts in the regulatory landscape.

We also advise on commercial issues including tech transfer, reimbursement, licensing, and more.

With Hogan Lovells, you can prepare for future success.

Contacts

Representative experience

We have advised human tissue companies on how to transition a product from 361 HCT/P status to licensure as a biologic under section 351 of the Public Health Service Act.

We have assisted leading pharmaceutical companies in determining the appropriate classification of their tissue products in the EU.

We have advised gene therapy companies on genotyping programs.

We obtained Healthcare Common Procedure Coding System (HCPCS) codes for cellular therapies.

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