Quality Assurance
Compliance is integrated throughout every stage
of the product’s full life cycle at LKtime Biotech. Throughout our service endeavors,
we uphold research and development quality, as well as product quality, as the vital
essence of the enterprise. Steadfastly committed to our quality policy of
"Quality First, Process driven, Pragmatic and Fact-based, Continuous
Improvement", we have established and implemented a scientific,
systematic, and effective quality management system. This ensures that our clients
are consistently provided with products that fulfill their intended use and adhere
to registration requirements.
Grounded in the "Quality by Design"
(QbD) principle during the research and development, as well as GMP
manufacturing processes, our quality management system is designed by referring
to GMP, cGMP, and ICH Q8, Q9, and Q10 guidelines. This comprehensive system
comprises 16 subsystems, encompassing both the Research and Development Quality
Management System and the Production Quality Management System. This meticulous
approach ensures that our early IND submissions and subsequent BLA filings adhere
to relative regulatory requirements.
High Standard Quality Management System
Registration and Declaration
LKtime Biotech’s registration team provides comprehensive
CMC regulatory support for various biopharmaceutical development projects,
including IND/BLA filing services for domestic and international markets. Our
registration and regulatory team has extensive experience in registration application
in China, the United States and Europe, fully understands the laws, regulations,
and communication mechanisms of various regulatory agencies, and can provide
comprehensive regulatory strategy guidance for clients throughout the full
product development lifecycle.
LKtime Biotech’s registration team aims to
provide our clients with comprehensive registration and regulatory services, including
CMC consultation, assistance in communicating with regulatory agencies
(pre-IND, pre-NDA, review process, etc.), inspection of research and
manufacturing sites, preparation of CMC-related CTD documentation, assistance
in responding to review comments and submitting supplementary information. We possess
the capability to prepare documentation that meets the registration requirements
of China, the United States and Europe.
Project Management
LKtime Biotech strictly adheres to international
standards, consistently upholding a customer-centric, “being your most trustworthy
partner” philosophy of high-quality services. Driven by the dual engines of an
innovative technology platform for accelerating processes and reducing costs,
as well as a scientifically robust project management system, the company
leverages its solid professionalism, rapid responsiveness, and exceptional
delivery rate to achieve a 100% renewal rate from its existing clients.
The project management team has experience in
the whole life cycle of project management, including manufacturability assessment,
high-quality early-stage pharmacology and toxicology study samples production,
process development, clinical application support, clinical samples production,
and commercialization production. The project leads are either department heads
or managers with over 5 years of industry experience. The project managers have
at least 3 years of project management experience and have undergone PMP
training in project management knowledge. All project members demonstrate
strong professionalism and a sense of responsibility, ensuring efficient and
robust project operations, and timely high-quality deliveries.
Based on client's requirements, regular progress
reports are conducted, stage-gate deliverable reviews are performed, and ad-hoc
technical communication meetings or periodic monthly communication meetings are
arranged.
Ensuring information security, project member
access privileges are granularly assigned, with only designated project liaison
personnel having access permissions to corresponding data.
