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Quality and Compliance

Wisdom has established a quality management system compliant with GMP standards of major global regulatory authorities such as NMPA, EMA, FDA, and PMDA, covering the entire process from development to early and late-stage clinical research and commercialization. Through routine self-inspections and dozens of customer audits conducted annually, the system undergoes continuous improvement. The company has successfully passed over 50 official audits by key regulatory authorities including USFDA, NMPA, Korea MFDS, and Japan PMDA. With our advanced quality management system and stringent quality control measures, we safeguard the research, development and production of pharmaceuticals worldwide.

Quality Policy

To win with product quality and service quality, we continuously produce pharmaceuticals that meet international quality standards such as those of China, the United States, Europe and Japan, becoming an excellent pharmaceutical manufacturer.

Quality Monitor

Continuously improve through annual self-inspections;
Engage senior FDA quality consultants to guide quality system improvement and daily quality supervision;
Continuously improve through dozens of customer audits annually;
Maintain ongoing compliance of the CGMP quality management system with NMPA, FDA, ICH and EMA requirements.

Quality Management

Strictly comply with the relevant laws and regulations of the WHO;
Establish a quality management system based on not only the GMP standards of the mainstream countries and regions such as China, the US and EU, but also PIC/S guidelines and ICH guidelines.
Establish an independent quality assurance department and achieve comprehensive management of quality system elements based on the scope of GMP activities;
Establish cGMP production workshops compliant with international standards (covering conventional APIs, highly hazardous APIs, cytotoxic APIs, peptide APIs and preparations), while consistently maintaining high-standard quality monitoring requirements;
Conduct a comprehensive lifecycle management covering product development, technology transfer, clinical-stage production and commercial-stage manufacturing;
Establish various GMP computerized systems to cover all aspects of GMP management;
Comprehensively ensure that products consistently meet expected requirements and quality specifications.

Quality Control

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.

We have six QC platforms:

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

REGISTRATION APPLICATION

We provide integrated registration application services including chemical research, process research, impurity research, and analytical method research. In addition to completing the registration of our own projects, we can also assist clients in accomplishing theirs.

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.

REGULATIONS

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.

Quality and EHS

Quality&EHS

Quality and Compliance

Quality Control

We have six QC platforms:

REGISTRATION APPLICATION

REGULATIONS

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