Comprehensive Regulatory Assessment
- Conducting in-depth evaluations of pharmaceutical products to determine their regulatory classification, eligibility, and pathway for registration with the SFDA.
- Identification of potential compliance gaps and strategic recommendations to ensure product alignment with current SFDA requirements.
- Evaluation of supporting technical documentation and dossiers for accuracy and completeness.
End-to-End Product Lifecycle Management
New Product Registration:
- Regulatory Strategy Development: Analysis of product type and origin to determine appropriate registration pathways.
- Eligibility & Classification Review: Preliminary assessment to confirm product scope under SFDA regulations.
- Dossier Preparation: Compilation of eCTD, including administrative, quality, non-clinical, and clinical modules.
- Application Submission & Follow-up: Electronic submission via SFDA systems and continuous liaison with authority representatives to track application status and address queries.
Variation Management:
- Regulatory Impact Analysis: Evaluation of proposed product changes / variations (e.g., formulation, labeling, packaging, manufacturing site) to determine classification (minor/major) and submission requirements.
- Documentation & Compliance: Preparation of variation applications with supporting evidence and ensuring alignment with SFDA guidelines.
- Authority Communication: Representation and response handling with SFDA during the evaluation phase.
Renewal Procedures:
- Monitoring & Alerts: Proactive tracking of product registration expiration dates to initiate renewal activities in a timely manner.
- Documentation Preparation: Compilation of updated technical and administrative documents, including post-marketing data and pharmacovigilance reports if required.
Ongoing Regulatory Intelligence & Updates
- Continuous monitoring of SFDA regulatory updates and changes.
- Dissemination and sharing of summarized regulatory insights tailored to client portfolios.
- Advisory on how upcoming regulatory shifts may impact product compliance, and strategic planning for adaptation.
General Regulatory Consultation
- On-demand guidance for queries related to local regulatory procedures, compliance expectations, labeling standards.
- Risk assessment and mitigation strategies for regulatory delays or challenges
