API solutions

Chemical Process ( R& D)

Continuous Improvement to support Drug Development Innovation.

We support for process design / route scouting , safety evaluation , optimization , Design of Experiments (DoE), process validation and continuous process improvement with more safer , more robust and greener processes. Advances in Flow chemistry and Biotransformation exemplify those efforts and apply to projects at different stages.

Key Analytical services

1. Analytical method development, validation and transfer .

2. Stability testing

3. API reference standard qualification

4. Spectroscopic structure confirmation

5. Raw material , In-Process control and release testing

6. Product Identification

7. Microbiology testing – Aseptic , Endotoxins , water testing

R& D Capabilities

a. Reaction optimization to reduce costs and maximize output .

b. Catalysts screening and optimization

c. Crystallization studies

d. API synthesis

e. Impurity profiling and characteristics

f. Lab , Kilo , Pilot plant facilities

Analytical services

Comprehensive services to support Manufacturing

The Analytical team at Neghagreenlab provides comprehensive analytical support to process development , Production and testing services for both drug substances and drug products . Our team conducts Method development , Validation , Verification and transfer to support projects through life cycle from pre-clinical and commercialization . We can provide in house stability studies , structural illustrations , impurity preparations /Characterizations , cleaning validations and more ..

Analytical Equipments

1. Chromtaography :
Gas chromatography , HPLChromatography , Preparative HPLChromatography

2. Spectrometry : UV -VIS Spectrometry , FT-IR.

3. Physical and chemical testing : pKa log P/D test , HS KF -V20,
TOC , Melting point detector .

4. Stability study chambers .