IP Fundamentals

INTELLECTUAL PROPERTY

Gear pledges that it shall not divulge or disclose any confidential information to third parties, without the written consent of the customer, nor would it use the information for any other purpose not consented or agreed by the parties.

Without prior written consent of the customer, Gear shall not use any patented technology related to custom projects

Quality audit：audit of raw material suppliers to ensure that the quality and quantity of raw materials supply; customer acceptance of my company's audit to ensure that our quality, customer service so that customer satisfaction.

Quality control： from the "people, machines, materials, France, Central," five strict requirements and implementation.

Validation management： mainly refers to the validation system, such as: cleaning validation, process validation, equipment validation, analytical and validation methods.

QC Department offers full analytical testing services from raw materials to products including analytical method development and analytical method validation, analytical testing and release, impurity analysis, solvent residue analysis, analytical instrument validation, clean validation, compound structure identification, chiral compounds Separation and so on.

QC has established a perfect Quality control process. Based on the guideline of GMP and ICH in China, ISO9001 has established the internal control standard management standard of the Company, which covers the testing standards of raw materials, intermediates and end products. 

Scale up and GMP certified manufacturing facilities can meet strict quality requirements and audit criteria to assure the quality of CMO services and products for our clients.

QC Equipped with state-of-the-art analytical instruments: HPLC, GC, Mass, Melting Point Meter, NMR, Prep-LC, dissolution bath, UV，SFC Prep-LC and more 

QA

Quality management system

QC

Our Quality management system is based on ISO9001, ICHQ7 as a guide to the overall quality management system. Under the quality assurance department-led, all various functional departments participate into, from buying the starting materials to send all cargoes. Quality management system has passed ISO9001: 2015 certification, aim to achieve ICH-Q7A standards finally.

Project Management

Our customer-focused Project Management System provides excellent & real-time, transparent & effective services for customers. The project starts from consulting to final commercial manufacturing, supporting update information to customers with perfect confidentiality mechanism, to assure thus a system both synchronized and regulated.