G&L Scientific España
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.
- Regulatory Development / Filing Strategy
- Marketing Authorisations
- Publishing and Submission
- Lifecycle management
- CMC Compliance
Global and Local
The team at G&L has proven success in working directly with local authorities in established and emerging markets around the world on behalf of our clients, with our most senior colleagues having in excess of 25 years’ global experience. This exposure to different regulations and agency nuances and cultures has proven to be of great benefit to our clients.
When required, we can call upon local members of our ‘Orbis’ network of partners, which spans over 100 countries, to provide additional local, strategic or hands-on expertise.
In-country expertise when and where you need it.
Consultancy services in Regulatory Affairs to Pharmaceutical and Biotechnology companies.