>> Contract Research Organization(CRO)
YANZ provides a full complement of clinical services for the pharmaceutical and biotech industries including the management and implementation of Phase I-IV clinical trials, such as Clinical Trial Program Design & Protocol Development, Project Management, Medical Writing, Clinical Trial Monitoring, Data Management, Biostatistics, Clinical Trial Report Compiling etc.
To make sure the clinical trial progress meets study objectives and regulatory compliance, YANZ has established a whole set of internationally recognized project management systems and Standard Operation Procedures, Quality Assurance systems. Besides, our team members for example Project Managers, CRAs, Statisticians are Medical, Pharmaceutical or Statistics backgrounded, all are highly-experienced and GCP trained.
>> Site Management Organization(SMO)
To make sure the clinical trial progress meets the requirements defined by GCP and Clinical Trial Protocol, YANZ provides clinical trial site management service to researchers by dispatching of CRC for non-medical judgment affairs for example investigators coordination, progress report submission. Similar to CRO, our CRC team members are Medical or Nursing backgrounded, all are experienced and GCP trained.
>> Product Technology Transfer
No matter new products scaling up from lab to factory or old products relocation from place A to B, all will involve the knowledge from both R&D and engineering, for example we need to define the process steps and process parameters, also we need to specify equipment type and equipment configurations; Besides, we need provide documented evidences that all the transfer progress are met regulatory requirements.
Thus, the product technology transfer progress is team work which will involve the activities from R&D, process and validation; obviously, this is what YANZ struggling for and our advantages. For new products scaling up, YANZ provides the service which includes but not limited to establish scaling up execution & testing protocols, define process flow diagram, help clients to select & configure equipment’s, validation etc. For old products relocation, YANZ provides the service which includes but not limited to establish process & equipment optimization protocols, process validation etc.
>> Regulatory Affairs
In Medical, Pharmaceutical and Food Industry, YANZ provides regulatory affairs service for example product registration and market access for both Chinese and international market such as Drugs, Diagnostics, Medical Devices, Cosmetics and Dietary Supplements. Strict management procedures are implemented by our regulatory specialists to protect clients’ Know-How from leakage.
CHINESE MARKET
|
|
INTERNATIONAL MARKET
|
1) Drugs
> Clinical Trial Registration
> New Drugs Application
> Generic Drugs Registration
> Import Drugs Registration
> Pharmaceutical Excipients Registration
> Primary Packaging Components Registration
2) Medical Devices
> ClassⅠMedical Devices Recording
> ClassⅡ,Ⅲ Medical Devices Registration
> Import ClassⅠMedical Devices Recording
> Import ClassⅡ,Ⅲ Medical Devices Registration
> ClassⅠIVDs Recording
> ClassⅡ,Ⅲ IVDs Registration
> Import ClassⅠIVDs Recording
> Import ClassⅡ,Ⅲ IVDs Registration
3) Dietary Supplements
> Dietary Supplements Recording
> Dietary Supplements Registration
> Import Dietary Supplements Recording
> Import Dietary Supplements Registration
4) Cosmetics
> Common Cosmetics Recording
> Special Cosmetics Registration
> Import Common Cosmetics Recording
> Import Special Cosmetics Registration |
|
1) Drugs
> ANDA, USA
> IND, USA
> NDA, USA
> DMF Preparation, USA
> NDC Registration, USA
> CEP/COS Application, EU
> EDMF Preparation, EU
> Generic Drugs Registration, EU
> Traditional Herbal Products Registration, EU
> TGA Registration, Australian
2) Medical Devices
> FDA 510(K) Registration, USA
> Establishment Registration, USA
> D-U-N-S® Number Registration, USA
> CE Marking, EU
> European Authorized Representative Service, EU
> CA Registration, EU
|
