Biotin CEP Grade|Tacrolimus CEP Grade|Cytisine--Zhejiang Kingland Pharm

Business Model

Model 01-Classic sourcing and distribution

Initial Evaluation

Vendor Screening
Producer Profile Mapping
Price Evaluation
On site Vendor Evaluation

Technical and Production Capability Evaluation
Supply Security and EHS Evaluation
Quality and Document capability Evaluation
Continuous Service in Win-Win model

Supplier chain maintains
Technical and Document support
Analytical testing service
Transparent communication with customer and supplier
Fully respect IP as part of our unyielding value

Model 02-Upgradation to the Regulated market

- Initial Vendor Evaluation

- Project marketing analysis and expanding

- Support on product technology on synthesis and analytical issue

- Support on DMF(eCTD) to USFDA and EDQM for API registration

- Doing mock authority inspection and gap evaluation

- On-site training on quality system management

- Support to prepare customer audit and CAPA response

- Support to prepare authority inspection and CAPA response

Model 03-Un-available APIs for Regulated market

Technical evaluation
IP evaluation

On-site GMP condition evaluation
Project schedule design

API Quality study
Process validation
ASMF preparation

ASMF submission
GMP compliance improve
Product marketing

New Project - API Development Process from Lab Scale to ASMF Submission

Initial Evaluation

On site Vendor Evaluation

Continuous Service in Win-Win model