Regulatory

Regulatory oversight in clinical trials ensures the safety, efficacy, and ethical conduct of studies involving human participants. With over 20+ years of experience with FDA, EMA, European, and international regulatory authorities, our Regulatory affairs team helps you proactively plan your regulatory strategy and streamline your regulatory compliance systems and processes with our end-to-end regulatory services.

From helping our clients understand the latest regulatory requirements, our teams proactively work with our clients to design a comprehensive regulatory compliance blueprint, helping throughout the product development life cycle by leveraging our AI-based regulatory information management algorithms.

We conduct a prior gap analysis to help you build a comprehensive regulatory roadmap based on local regulatory guidelines. Our regulatory experts also help you write and submit CMC documentation, Common Technical Documents (CTDs), IND applications, New Drug applications (NDAs), and Market Authorization Applications (MAAs).

Our Services:

Regulatory Project Management

Regulatory Strategy & Due Diligence

Regulatory Life Cycle Management

CMC Regulatory Affairs Consulting

E-CTD Preparations & Submissions

Regulatory QMS & Support