Custom Synthesis

Manufacturing/Synthesis support for

• Synthesis of API’s and Intermediates
• Reference standard preparations
• Synthesis of different types of Impurities

Formulation Development

Manufacturing support for different dosage forms like

• Inhalation products
• Pellets
• Solid Orals
• Injectables

Technology Transfer and Dossier Support

• End to end support for Formulation development and Analytical method development of various dosage forms like Inhalations/Aerosols, Solid Orals and Injectable products
• Electronic Common Technical documents (eCTD) /Dossier support

Analytical support

Certification of reference standards via full chemical analysis

• Method development and validation as per ICH guidelines.
• All type of analysis for chemical substances and Finished products
• Nitraso amine impurities validation and analysis
• Elemental impurities analysis by ICP-MS, GC-MS and LC-MS
• Isolation and characterization of impurities and degradation products
• 2D-NMR analysis
• TGA analysis etc