Navigate complex international regulations with confidence and avoid costly missteps. Our team guides your interactions with regulatory authorities such as the FDA (USA), EMA (EU), and TGA (Australia), securing approvals efficiently. Our services include strategic regulatory planning, expert representation in technical meetings, and comprehensive technical documentation.

Leverage the FDA’s special review policies to significantly increase your project’s commercial value and facilitate successful project transfers. Our expert team can help you secure designations such as: Fast Track Designation, Breakthrough Therapy Designation，Special Protocol Assessment，Regenerative Medicine Advanced Therapy Designation，and Orphan Drug Designation. We will conduct a technical review of your product, develop a special policy filing strategy and regulatory path, and provide optimization guidance for your non-clinical, clinical, and CMC materials to meet your subsequent development needs. 1．Fast Track Designation (FTD) offers flexibility by allowing submission at any stage of drug development. It fosters enhanced communication with the FDA through type B meetings and potentially leads to expedited review through priority review. The rolling submission of materials during the NDA/BLA phase enables timely feedback and guidance from the FDA. 2．Breakthrough Therapy Designation (BTD) includes all the advantages of FTD along with additional benefits. It enables early engagement with the FDA, providing development guidance as early as Phase I of clinical trials. Additionally, the project also receives the involvement and support of high-level FDA personnel. The submission deadline for BTD is no later than the EOP2 meeting. 3．Special Protocol Assessment (SPA)allows for obtaining the FDA's agreement on the scientific and rational basis of the Phase III clinical trial plan before its initiation. This streamlines the review process as the FDA assesses trial data based on the agreed plan, increasing the likelihood of marketing approval. Submission for SPA needs to be done before starting Phase III clinical trials. 4. Regenerative Medicine Advanced Therapy (RMAT) Designation is specifically designed for regenerative medicine products, offering similar benefits to BTD. The FDA provides priority support and priority review privileges for products granted RMAT designation. 5. Orphan Drug Designation (ODD): is intended for drugs developed for rare diseases or conditions, usually with a low incidence rate, affecting a small number of people. Drugs receiving this designation are entitled to special incentives and support during clinical development, such as market exclusivity, tax credits, and R&D cost deductions.

The FDA offers a variety of communication channels to support sponsors in navigating drug research and development successfully. Evergreen’s team of experts possesses extensive expertise in FDA meetings, adeptly guiding clients through relevant regulatory discussions to resolve development issues while maximizing your chances of obtaining valuable technical guidance and policy commitments from the FDA. We offer comprehensive support for a range of FDA meetings, including Type A, Type B, Type C, Type D meetings, and INTERACT meetings. 1.Type A Meetings: Address urgent issues impacting development plans or safety, such as clinical protocol disputes, unexpected safety findings, SPA rejection, or RTF concerns. 2.Type B Meetings: Cover key milestones in the product development plan, including: Pre-IND meetings, pre-EUA meetings, pre-NDA/pre-BLA meetings; post-action meetings that are required to be convened within 3 months after the FDA has taken regulatory action (excluding approval); and End-of-Phase (EOP) meetings to discuss transition to the next development phase. 3.Type C Meetings: Address product development and review topics not covered by other meeting types, offering flexibility for a wider range of discussions. 4.Type D Meetings: Resolve specific issues and provide timely feedback at critical decision points in the development program. 5.INTERACT Meeting: Designed for emerging products like neoantigens, personalized cell therapy, gene therapy, and new administration routes, offering early regulatory guidance from the FDA to prevent research delays.