Drawing on JOINN Laboratories' long-term R&D accumulation, the JOINN regulatory team boasts in-depth expertise in pharmaceutical regulations. It provides end-to-end regulatory consulting and registration services compliant with ICH, NMPA and FDA requirements across China, the US and Europe for innovative and generic drug sponsors throughout the full drug-development lifecycle, addressing key registration pain points and accelerating global product launch.
Beyond simple document drafting, we follow the core principle of "proactive regulatory strategy, full-cycle risk control and efficient registration execution". By engaging at early-project stages, we oversee dossier quality and review progress to support high-quality approval.
Full-spectrum, full-stage regulatory filing services covering strategy consultation, dossier drafting, submission, review response, meeting support and post-approval variation filing:
• Regulatory strategy consultation.
• CTA/IND/NDA/ANDA/BLA preparation, review and submission.
• CTD Module 1-5 drafting & compilation, including Module 2.4 Non-clinical Overview, Module 2.6 Nonclinical Summaries & Tabulations, plus clinical documents (clinical development plans, ICF templates, investigator brochures, risk management plans, etc.).
• Support for responding to review inquiries & drafting supplementary filing materials.
• Pre-IND/NDA meeting document preparation, review & on-site attendance support.
• Assessment of clinical-stage & post-approval variations, drafting supplementary application dossiers.
• Global regulatory compliance expertise
• Mastery of full CTD dossier modules
• Early-stage risk prevention mechanism
• Multi-disciplinary one-stop collaboration
• Rich experience handling complex review cases
• Early R&D: Custom regulatory strategies, standardized R&D compliance frameworks
• Clinical execution: CTA filing, variation filing, aligned IND dossier preparation
• Marketing application: IND/NDA/ANDA/BLA dossier compilation, submission & review follow-up
• Post-launch: Post-approval variation assessment, supplementary filings, long-term compliance maintenance
