REGULATORY SERVICES
Start Your Regulatory Journey with ND Global
Dealing with the intricacies of regulations specific to different countries can be a challenging task. At ND Global, our skilled team is committed to facilitating effortless adherence to local, national, and global standards while avoiding unnecessary delays.
ND Global supports Pharma Regulatory Affairs Professionals as essential liaisons between pharmaceutical companies and global regulatory agencies (FDA, TGA, MHRA, MCC, etc.). Our expertise aids in streamlined communication, ensuring activities like licensing, registration, development, manufacturing, marketing, and labeling comply with all rules. We facilitate seamless interactions, enabling regulatory success on a worldwide scale.
With ND Global, you’re not just another client – you’re a partner on the journey to a hassle-free registration process that paves the way for timely market entry.
IND (Investigational New Drug)
ND Global’s Regulatory Affairs (RA) team provides expert support in IND application, handling documentation, FDA communication, and ensuring compliance for safe administration to humans.
NDA (New Drug Application)
ND Global assists in the NDA application process, helping drug sponsors gain FDA approval for new pharmaceuticals in the U.S. We ensure meticulous preparation and compliance with regulatory guidelines.
Global Regulatory Services:
ND Global offers regulatory planning, compliance, and submission support for different regulations, such as Health Canada (CANADA), Medicines and Healthcare Products Regulatory Agency (UNITED KINGDOM), SFDA (SAUDI ARABIA), PMDA (JAPAN), TGA (AUSTRALIA), NMPA (CHINA), ANVISA (BRAZIL), SWISSMEDIC (SWITZERLAND).
We guide clients through individual country submissions and create a single, practical regulatory strategy roadmap that considers the needs of various regulatory authorities, all while minimizing time and maximizing resource efficiency.
