RegulatoryAffairs
Navigating regulatory requirements in Switzerland demands expertise, precision, and thorough understanding of local processes. Our Regulatory Affairs specialists offer strategic guidance and comprehensive support throughout every phase of your clinical development and regulatory submission process.
Our service include
Strategic Management
Strategic regulatory planning tailored specifically to your clinical objectives.
Efficient Submission Process
Preparation and management of regulatory submissions, ensuring adherence to Swissmedic and Ethics Committees guidelines and timelines.
Follow-up with Authorities
Follow-up with Swiss regulatory authorities, facilitating clear communication and efficient regulatory interactions.
Obtention and Maintenance of Authorizations
Expert assistance in obtaining and maintaining clinical trial authorizations and Ethics Committee Approvals.
Continuous Compliance Strategy
Continuous monitoring of evolving regulatory requirements, proactively adapting strategies to maintain compliance.
With GALSER, regulatory complexities are simplified, ensuring your clinical programs advance efficiently and confidently towards successful completion.
Faq
Feedback from our clients
“GALSER team has shown a great mix of professionalism, flexibility/adaptability and profound knowledge of the human research landscape in Switzerland”
01
/05
“A remarkable project leader who managed to deliver a high-quality protocol in a very short time”
02
/05
“We were impressed by GALSER’s strong relationships with the study sites and their ability to keep things moving despite the usual challenges. It really helped us stay on track”
03
/05
“Your level of detail and expertise really stand out. It’s been a real pleasure working together!”
04
/05
“The GALSER team guided us through the Swiss regulatory process with clear advice and great responsiveness. Their support made the entire submission much easier than we anticipated.”
05
/05
