Drug Development Solutions
- Route scouting; develop, optimize & scale-up with all requisite analytical development & regulatory support till process validation & filing of NDA
- QbD based process development; Process safety and hazard assessment; Critical parameter evaluation, process validation & stability studies
- Ownership of process with R&D till process validation & transfer to the plant
- Fee for service / FTE Business Model; IP belongs to customers
- State of Art Infrastructure including dedicated lab-space for handling of potent compounds
- Electronic Lab note books
- Scifinder®; Reaxys; Derwent World Patent Index on Delphion®; ACS® journals; Access to libraries at local premier academic institutions
- Method development & transfer
- Method validation & verification
- Stability studies
- Polymorph identification, studying polymorph transformation, Amorphous content estimation etc.
- Isolation and characterization of impurities
- Reference standard characterization
- Multiple State-of-Art Analytical Laboratories
- Expansive stability chambers at both Hyderabad & Vizag – stability samples stored at the location of manufacture
- General Analytical facilities such as HPLCs; NMR; GC-HS; GC-MS; LC-MS; UPLC with all required detectors including CAD; KF-Auto-Titrators; Particle Size Analyzers; TOC Analyzer; UV-Vis etc.
- Solid State studies: NMR with Solid State capability; XRD; FT-IR; DSC & TGA
- ICP-MS; MPLC; Prep HPLC; AAS; CE; UPLC-DAF-MS/MS etc.