Quality & Regulatory
Quality & Regulatory
Quality Excellence & Regulatory Compliance
Our Commitment to Quality
Our Commitment to Quality
At Apextide, quality forms the cornerstone of our operations, driving our dedication to delivering exceptional peptide and oligonucleotide products. Our comprehensive Quality Management System has been meticulously established to meet the stringent requirements of major regulatory agencies including NMPA, US FDA, and EMA, as well as international guidelines such as 21 CFR Part 210/211/820 and ICH Q7/Q8/Q9/Q10.
Under the direct oversight of our senior management, we have implemented a robust quality framework that ensures all CMC (Chemistry, Manufacturing and Controls) operations and process controls maintain the highest level of global quality requirements. This systematic approach, guided by our Quality Manual, enables us to consistently deliver products that exceed regulatory standards while fostering a culture of continuous improvement throughout our organization.
Quality Management System
GMP-Compliant Manufacturing Facilities
Quality Control Laboratories with State-of-the-art Equipment
Robust Documentation System
Risk Management Protocols
Change Control Procedures
Deviation Management
CAPA (Corrective Action and Preventive Action) System
Regulatory Standards
ISO 9001:2015 Certification
FDA Registration
Regular Regulatory Authority Inspections
Client audits
Documentation & Transparency
We provide comprehensive documentation including:
Batch Production Records
Analytical Testing Reports
Certificates of Analysis
Stability Reports
Method Validation Reports
Technical Support Documentation
Quality Assurance
Our dedicated QA team ensures:
Compliance with cGMP Guidelines
Implementation of ICH Guidelines
Regular Internal Audits
Supplier Qualification Program
Product Quality Reviews
Training Management
Address
Hangzhou Pharmaceutical Port
Fax
(086) 0571-8672-0235
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