Benefit from regulatory excellence across the entire lifecycle.
SFL’s leading regulatory experts provide strategic regulatory advice and hands-on operational support for drugs, biologics and advanced therapy medicinal products (ATMPs) including gene therapy products. Our experience covers all life cycle stages from development to registration and post-marketing activities.
Utilizing our Swissmedic establishment license, SME-status at EMA and a network of long-standing partners in US, Japan, Canada and other countries, SFL can act as marketing authorization applicant and MAH in Switzerland and the EU and conduct submissions to FDA, PMDA and Health Canada and other authorities.
See also SFL’s customized trainings in Regulatory Affairs for Pharma and Medtech.