The QC (Quality Control) team of Wisdom ensures our products and services comply with customer requirements. We strictly adhere to ICH guidelines and utilize advanced instruments to provide test for the entire production process. The QC team provides reliable data to the QA (Quality Assurance) team for product release.
Impurity and Solvent Residue Research Platform
(NMR(Bruker 600 MHz), HPLCS(equipped with VWD/DAD/CAD/ELSD/RID/FLD), GCS (Equipped with Headspace sampler such as FID/ECD/TCD), Dionex ICs 5000+,U(H)PLCs (Thermo Ultimate 3000,Vanquish,Water Hclass)
Genotoxic Impurity Research Platform
LCMS/MS(Thermo Q Exactive,ABSciex QTOF 5600), GCMS/MS(Shimadzu TQ8040), GCMS(Shimadzu), LCMS(Shimadzu), Dionex ICS 5000+/2000+
Crystal Type and Size Research Platform
Rigaku XPD,Malvern Mastersizer, PerkinElmer TGA/DSC)
Elemental Impurities Research Platform
(ICP-MS, Microwave Digestion System, Dionex ICS 5000+)
Microbial Research Platform
Microbial limit (Counting method), Method validation and verification, Endotoxin (Gel method and Colorimetric method)
Stability Research Platform
Stability research such as stress testing, acceleration and long-term stability and storage time
IND (Investigational New Drug) Application Service
Wisdom has an in-depth understanding of the policy environment in China and the United States, as well as the technical requirements for pharmaceuticals. The company provides the NMPA and FDA IND application services to domestic clients. The service targets ot only the cooperative clients but also those with separate IND application needs.
Project Management Service
The registration team review, edit, conduct technical evaluations and then finalize the IND/ANDA application documents for the clients. The designated project lead is specifically responsible for evaluating the submission documents, facilitating internal technical communication and submitting the application materials. After the submission of the application materials, the project lead will continuously monitor the review status and maintain communication with the regulatory authority to track the submission progress in real time. Upon approval of the submission, the project lead will also continue to be responsible for updates.
Advantages
The professional IND and ANDA research team is capable of providing full-cycle research, comprehensive project management, and regulatory application services, equipped with expert resources from NMPA and FDA review divisions to offer targeted technical, regulatory application strategy advice. We tailor registration application strategies for clients, assess potential regulatory risks, expedite submission, track review progress and facilitate rapid regulatory approval for clients.
Active Pharmaceutical Ingredient (API) registration application
Wisdom has an API registration team with over-20-year experience in domestic and international registrations. The team is well-versed in the registration processes of various countries and keeps abreast of the latest laws and regulations in real time. It provides efficient services covering project initiation research, documents preparation, submission, deficiency responses and routine maintenance. The team has completed registrations such as DMF, VMF, CEP and ASMF to meet global registration requirements.
Our regulatory department is responsible for communicating with regulatory authorities. We ensure compliance with the latest regulatory requirements. We manage operations in accordance with cGMP regulations.
Our regulatory department has been involved in the entire project management process from the very beginning. We consider all elements during project supervision, including project development, quality research, and production document preparation.
We have extensive experience in submitting official documents in CTD format. We can provide clients with comprehensive regulatory and registration support.
Telephone
0513-81292228
Email
sales@wisdompharma.com
Address
No 18, Qinghua Road, Sanchang, Haimen, Nantong, Jiangsu, China
4009968186
tl_liu@wisdompharma.com
yc_han@wisdompharma.com
