Regulatory Affairs

G&L provides end-to-end regulatory affairs services throughout the entire drug life cycle – from early development stage, through submission and licence approval to post-approval marketing maintenance.

Our experience covers all types of medicinal products, markets and therapeutic areas, involving small molecules, biologicals, biosimilars, ATMPs, cell therapy and gene therapy.

Our highly-respected management team has decades of experience in delivering regulatory solutions and strategic guidance to a wide portfolio of clients, tackling some of the most technically challenging projects, delivering successful client outcomes that are flexible and cost-effective and that offer exceptional value to clients from both commercial and scientific standpoints.