Life Sciences & Pharmaceutical Compliance
In the high-risk, high-barrier pharmaceutical and health sector，QTC with rigorous scientific standards and deep regulatory expertise, building compliance bridges to global markets。
Laboratory Testing Solutions (Testing Services)
Ensuring product compliance with pharmacopeia (USP/EP/ChP) and FDA standards
Microbial Limits Test
Screening for total plate count, mold/yeast, and pathogens (Salmonella, E. coli, Staphylococcus aureus).
Physicochemical & Heavy Metals
Heavy metals (Pb, As, Cd, Hg), pesticide residues, solvent residues, and active ingredient assay.
Stability Studies
Accelerated and long-term stability studies to determine product shelf life.
Supply Chain Quality & Auditing (Inspection & Auditing)
Full-chain GMP compliance check from raw materials to finished products
GMP Mock Audit
Simulate FDA or NSF official audit processes, conducting a comprehensive pre-inspection of the factory's quality system, facilities, equipment, and production records.
Supplier Second Party Audit
Conduct on-site audits of raw material (API/excipients) and packaging material suppliers to ensure the upstream supply chain meets GMP requirements.
EXCiPACT Excipient Certification
Provide third-party GMP/GDP certification coaching compliant with EXCiPACT standards for pharmaceutical excipient manufacturers.
High-end Consulting & Empowerment
Solving FDA Warning Letters, Registration, and High-end System Certification challenges
NSF/ANSI 455-2 Consulting
Dietary supplement GMP certification coaching. Assist in establishing a quality system meeting NSF Grade A/B requirements, with a pass rate up to 98%.
FDA 483 Remediation
Targeting 483 observations from FDA inspections, providing Root Cause Analysis (RCA) and CAPA remediation plans, and responding to Warning Letters.
Label Review & Registration
FDA facility registration, product listing, and Supplement Facts compliance review.
Истории успеха клиентов
Основанные на данных решения по комплаенсу, создающие реальную бизнес-ценность
Expert Insight
"In the life sciences field, Compliance is Life. QTC focuses on deep alignment with NSF/ANSI 455-2 and 21 CFR 111, assisting enterprises in establishing a comprehensive error-proofing mechanism from laboratory management to the production site, ensuring every pill can withstand the most stringent inspection."