Why Choose Solstice
Purpose-Built for Regulatory Excellence
We pride ourselves in providing cutting-edge regulatory solutions, ensuring that our clients are equipped with current, relevant information to address the dynamic challenges of regulatory compliance.
AI-Enhanced Innovation
We leverage AI to enhance regulatory submissions, workflows, and insights. Our cutting-edge tools streamline processes, reduce turnaround times, and deliver actionable intelligence. This approach ensures better outcomes for our clients.
Talent Driven Excellence
We source and retain top talent through a strong global network of skilled professionals for complex regulatory tasks. Our experts integrate seamlessly into your teams, ensuring efficiency and scalability.
Regulatory Affairs
Ensure regulatory compliance and prepare submissions and applications to agencies, such as the FDA, the European Medical Association, & other agencies, Addressing HA questions and securing right strategy for success.
Life Cycle Management
We provide scalable solutions for approved assets, ensuring seamless compliance across critical areas such as CMC, labelling and market regulations. Our services are designed to optimize compliance processes.
Predictive Analytics
Use of AI to predict the likelihood of of approval for new drug applications by analyzing historical data and identifying key factors that influence regulatory decisions.