Global Scientific And Regulatory Affairs
Navigating the complex landscape of scientific and regulatory affairs is a challenge for biotech companies. That's why our team is committed to providing solutions tailored to meet these unique needs.
Our Mission
Our mission is to connect biotech companies with the right preclinical choices through our ClinicReady services and guide them through the global clinical development continuum with our GlobalReady solutions. We act as a surrogate development department for start-up companies, assisting them in demonstrating safety and preliminary clinical proof of concept of their assets.
Regulatory Strategy Development
We devise regulatory strategies to navigate diverse regulatory landscapes, ensuring timely submissions and approvals.
Liaison With Regulatory Authorities
We serve as the primary liaison between our clients and regulatory authorities, maintaining open lines of communication and addressing inquiries promptly.
Surrogate Development
Acting as a surrogate development department, we assist start-up companies in demonstrating safety and preliminary clinical proof of concept of their assets.
Streamlined Marketing Application
Our medium-term aim is to offer a streamlined and flexible marketing application experience to our clients through our fully integrated functions within SRMA, harnessing our comprehensive global expertise.
Adherence To GCP Standards
Clinical Practice (GCP) standards, safeguarding the integrity and ethical conduct of clinical trials.