中文
中文
Analytical method transfer, validation/verification (physicochemical, biochemical, cellular, and microbiological);
Release testing for in-process intermediates, bulk drug substances, and finished drug products;
Sampling and testing for utility systems: water, environment, gases, etc.
Release testing for drug substances and packaging materials.
BSL-2 certification, capable of independently undertaking testing and method validation services for AAV, cell products, live microecological products, and other BSL-2 samples.
Disinfectant validation services.
Stability study protocol design;
Storage, sampling, and testing of stability samples;
Stability study trend analysis;
Stability study summary and comparability analysis.
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Pillar |
Service Offerings |
Key Responsibilities & Capabilities |
|
Raw Material Control |
Conducts testing and release for all incoming materials, including media, reagents, excipients, and primary packaging materials. |
Establishes specifications based on USP/EP/ChP standards and performs identification, potency, and safety testing to ensure compliance from the very source of production. |
|
Process Control |
Implements in-process controls (IPC) and in-process testing (IPT) throughout the manufacturing process. |
Monitors critical attributes such as titer and concentration in real-time, providing immediate feedback to ensure continuous process control. |
|
Release Testing |
Performs comprehensive batch release testing for both Drug Substance (DS) and Drug Product (DP). |
Annual testing capacity exceeds 100 batches, with established platforms covering mAbs, bispecifics, fusion proteins, vaccines, and more. |
|
Stability Studies |
Designs and executes stability studies compliant with GMP and ICH guidelines. |
Equipped with controlled stability chambers to assess product degradation pathways and shelf-life through real-time, accelerated, and stress (forced degradation) studies. |
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Module |
Core Value |
Key Service Offerings |
|
GMP Compliance |
Ensuring operations fully comply with global Good Manufacturing Practice regulations. |
• Compliance Consulting: NMPA/FDA/EMA regulatory interpretation and strategic recommendations. • System Establishment: Assistance in building a robust Pharmaceutical Quality System (PQS). • New Facility Planning: Developing compliance plans for new facilities/products. • Audit Services: Gap analysis, mock audits, and supplier audits. |
|
Computerized Systems & Data |
Ensuring lifecycle compliance and data integrity of computerized systems. |
• System Establishment: Defining the Computerized System Assurance (CSA) framework. • Compliance Support: GxP assessments, data assessments, and control strategies. • Validation & Maintenance: System validation execution and ongoing compliance maintenance. |
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Engineering & Facility Equipment |
Ensuring that facilities, utilities, and equipment meet regulatory requirements from design to operation. |
• Engineering Management: New facility planning, design review, and GEP oversight. • Equipment Qualification: Full lifecycle guidance from URS, FAT/SAT through to 3Q (IQ/OQ/PQ). • Regulatory Alignment: Tracking and implementing relevant regulatory changes. |
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Validation & Risk Analysis |
Ensuring continuous process robustness through systematic validation and risk management. |
• Validation Management: Leading VMP, Process Validation (PPQ), and Cleaning Validation. • Risk Analysis: Services including cleaning risk assessment and cross-contamination risk assessment. |
|
MAH Services |
Providing full-chain quality operation support for Marketing Authorization Holders. |
• System Establishment: Assisting in building the MAH quality system. • Operation Guidance: Supporting B-license application and daily quality operations. • Audit Management: Conducting audits of Contract Manufacturing Organizations and suppliers. |
|
CMC Services |
Providing technical and regulatory support for pharmaceutical development and manufacturing. |
• Technology Transfer: Conducting gap analyses, reviewing transfer plans and reports. • Change Management: Supporting site transfers and various changes for regulatory filing. • Process Support: Providing support for process characterization, process validation, and stability studies. |
Act as agent for preparing and submitting domestic and overseas IND applications (including CMC communication meeting applications)
Provide full life cycle regulatory support for drug R&D
Provide full life cycle regulatory support for drug R&D
Support for FDA/EMA/other regulatory body submissions
Pre-IND meeting preparation
IND dossier preparation (CMC, preclinical, clinical)
CMC communication and management during development
IND submission and follow-up
Clinical development change management
Pre-BLA dossiers and submissions
BLA dossier preparation (CMC, preclinical, clinical)
Post-approval change management
Post-approval supplements and lifecycle management (CMC)
Support for post-approval product changes and supplementary filings
Post-approval change management
Change implementation (production site, production process, formulation, specifications, etc.)
Change risk assessment
Post-approval supplement preparation and submission
Feasibility assessment and analysis based on project objectives.
Formulation of strategies, communication plans with regulatory agencies, and research and development plans.
Preparation of project initiation and feasibility reports.
Provide full-process support for R&D projects and assist in communication with regulatory agencies.
Develop a regulatory strategy and a detailed implementation plan for the entire project.
Provide CMC strategy and technical support, and conduct regular reviews of R&D progress.
Assist in the preparation of key documents such as CMC development plans, stability plans, and impurity research plans.
Participate in and support the preparation of key development milestones and project reviews.
Organize and coordinate dossier compilation and review.
Provide CTD module compilation and review, and fill in and review CMC modules.
Assist in the preparation of responses to questions, and dossier revisions and supplements.
Represent the client in interactions with regulatory agencies.
Assist in the review and approval process, and follow up on review and approval progress and feedback.
Assist in post-approval change management and lifecycle management.
Assist in GMP inspections and GMP compliance.
Proven Track Record: Dozens of successful IND/BLA filings in China, the US, and Europe, covering complex molecules such as bispecific antibodies and recombinant proteins.
Top-Tier Team: Core members possess extensive end-to-end regulatory affairs experience, supported by an international advisory network that includes former FDA and CDE reviewers.
Authoritative Network: Long-term, close collaborations with global regulatory authorities and industry associations, providing cutting-edge policy insights.
Forward-Looking Strategy: Mastery of regulations and review philosophies across different countries enables precise regulatory and development strategies from the early R&D stage, enhancing success rates.
Problem-Solving Expertise: Skilled in integrating technical evidence with regulatory rationale to efficiently resolve critical issues during review and accelerate the approval process.
Standardized Processes: Established highly efficient, standardized procedures for documentation, review, and submission, ensuring quality and timeliness.
Dynamic & Agile Response: Real-time tracking of regulatory updates allows for swift strategy adjustments, ensuring submissions always meet the latest standards and securing a competitive edge.
Engaging early in the R&D phase to define a clear regulatory pathway based on global trends and oversee critical milestones.
Ensuring full data compliance throughout the R&D and manufacturing process, maintaining dynamic communication with regulatory authorities, and optimizing strategies flexibly.
Representing clients in efficient and transparent regulatory interactions, aiming not only for approval but also for building long-term product competitiveness in the market.
