Quality
ISSAR offers standardized and uncompromised quality of Peptide drugs based on the project needs. Our company’s research and development is in accordance with the ICH and USP guidelines. We are cGMP approved and equipped with a US-FDA-compliant manufacturing facility.
The Quality support is initiated and adhered to at every stage of drug development process and continued even after the product is delivered.
Our Quality services includes
• Recognition of quality needs when generating a quote
• Confirming an order
• Designing the most suitable manufacturing process
• Controlling product quality at each production step
• Informing clients in a timely fashion
• Conducting finished product testing
• Generating the Certificate of Analysis (CoA)
• Releasing the final product.
Quality support further continues after product release in the form of Stability studies and Regulatory filing assistance.
At ISSAR, we enable safety of the employees and the environment from the hazardous release of chemicals during the development and manufacturing process of the peptide molecules by ensuring the SOP systems are comprehensive reaching every aspect of material flow. We stick to the cGMP practices and mandate the ICH guidelines at the site of research as well as production.
Safety, Environment and Health
Machinery
AUTO-SYNTHESIZER-LARGE-SCALE
AUTO-SYNTHESIZER-SMALL-SCALE
GRACE-PURIFICATION
LYOPHILIZER-LARGE-SCALE
WETLAB
