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.

G&L expertise

We deliver projects and engagements of any size, from a few hours’ strategic advice or regulatory intelligence, to large, global, multi-year engagements. We have the expertise, scalability and global reach to respond quickly to any client request for assistance – providing a local service on a truly global basis.

We are proud of the excellent reputation we have built for delivering regulatory services that are quality-focused and that we are renowned for forging collaborative relationships with client stakeholders.

Our key areas of expertise and service are outlined in this section and include:

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