Regulatory Services

Our deep regulatory expertise, combined with strong clinical operations capabilities, enables us to deliver tailored regulatory support aligned with your product type, development stage, and global regulatory requirements. Using AI-driven insights and digital regulatory tools, we help you define a clear regulatory strategy early in development—ensuring preparedness from first-in-human studies through market approval and post-marketing activities.

A well-defined regulatory plan is a strategic asset. Our technology-enabled approach provides end-to-end visibility of regulatory pathways, anticipates risks, and supports informed decision-making throughout the product lifecycle. As your regulatory partner, we deliver the right support at the right time, supported by an established global network of regulatory and clinical experts.

We proactively identify potential challenges, enable efficient interactions with regulatory authorities, and support collaborative, data-driven regulatory engagement.

Our Regulatory Services Include:

• AI-enabled regulatory strategy and clinical regulatory guidance
• Digital clinical quality management systems (QMS) and compliance oversight
• Preparation, compilation, and electronic submission of regulatory dossiers
• AI-assisted response management to regulatory authority queries
• Custom digital training for investigators and site staff on regulatory guidelines
• Safety reporting and automated periodic literature surveillance
• Preparation of regulatory documentation, including: 
  • Investigator’s Brochure (IB)
  • Clinical Study Protocols (CSP) and Clinical Study Reports (CSR) for drugs and biologics 
  • Clinical Investigation Plans (CIP) and Clinical Investigation Reports (CIR) for medical devices (ISO 14155)
  • Clinical Performance Study Protocols (CPSP) and Clinical Performance Study Reports (CPSR) for IVDs (ISO 20916)

Our AI and digitally enabled regulatory services deliver speed, accuracy, and compliance—helping you navigate complex regulatory landscapes with confidence and efficiency.