Business Model
Model 01-Classic sourcing and distribution
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