Our regulatory support services are designed to navigate complex global requirements, ensuring timely approvals and lifecycle management of pharmaceutical products.
Regulatory Support Services
Dossier Compilation & Submission Expertise
We compile high-quality dossiers in CTD and eCTD formats, customized for each market’s regulatory expectations to accelerate your product approval timeline. Whether submitting an IND to initiate clinical trials or filing an NDA or 505(b)(2) or ANDA for a generic drug, our team provides tailored guidance and regulatory intelligence.
Regulatory Strategy Development
We offer strategic regulatory planning to streamline product’s development pathway and customize it based on different global agency requirements, securing the most efficient path to approval.
Continuous Regulatory Support
Our team offers strategic guidance and hands-on assistance in maintaining regulatory approvals and meeting post-marketing obligations like submission of regulatory variations, annual reports and labelling updates to ensure continued compliance with global pharmaceutical regulations throughout the product lifecycle.
Global Regulatory Support
By offering consistent global regulatory support, we empower to expand into new markets confidently, with the assurance of compliance and strategic insight. As an extension of products to different location of the globe, we offer expert guidance and hands-on assistance for submissions, lifecycle management, and ongoing compliance.