Phase-Specific Services in Pharmaceutical Development
Vikasith ’s R&D organization supports every stage of the pharmaceutical lifecycle — from discovery through commercial manufacturing.
Drug Discovery
During Drug Discovery, our scientists focus on lead identification and lead optimization, leveraging structure-based design and synthetic innovation.
Pre-Clinical Development
In the pre-clinical phase, we deliver process development tailored for scalability, analytical method development, and gram-scale synthesis to support toxicology studies. The team also conducts impurity identification, physicochemical property analysis, and stability studies essential for IMPD submissions.
Clinical Development (Phase I-III)
At the Clinical Phases (I–III), our services include non-infringing route development, QbD and DoE studies, impurity spike and purge analysis, and process characterization. We perform process engineering assessments (FMEA), GTI and nitrosamine impurity evaluations, and hazard and operability (HAZOP) studies to ensure process safety. Additional expertise includes polymorph studies, reference standard preparation, analytical validation, and multi-kilo synthesis under cGMP standards.
Commercial Manufacturing
For the Commercial Phase, Vikasith provides complete process validation, multi-ton manufacturing, and regulatory filing support for global submissions. Our teams continue to conduct stability studies, prepare Drug Master Files (DMFs), and offer comprehensive post-approval support to ensure long-term product integrity and compliance.
Phase Specific Services in Pharma
- Lead Identification
- Lead Optimization
- Process development to fit the scale
- Analytical method development
- Gram scale synthesis to support toxicology studies
- Impurity identification and characterization
- Physicochemical property study to support IMPD
- Stability studies
- Non-infringing route development & optimization
- QbD/DoE study (CQA and CPP assessment)
- Impurity Spike and Purge Studies
- Process characterization studies
- Process Engineering Assessment (FMEA)
- GTI and Nitrosamine impurities assessment and control strategy
- Process Safety/Hazop Assessment
- Polymorph Study
- Reference standard Preparation and Qualification
- Analytical method validation
- Multi Kilo synthesis under cGMP
- Process Validation
- Multi ton commercial manufacturing
- Global regulatory filing and support
- Stability studies
- DMF support