Chemistry, Manufacturing & Controls
- Process development for small molecules and biologics.
- Analytical methods; stability; comparability; scale-up and CDMO selection.
- Helping clients develop scalable, regulator-ready manufacturing processes for small molecules and biologics.
- Selecting and auditing CDMOs in India with the right capabilities (GMP, sterile, biologics, etc.).
- Overseeing process validation, stability studies, and comparability exercises before clinical material production.
- Preparing CMC sections of IND/IMPD dossiers, ensuring that the manufacturing story is consistent, reproducible, and audit-ready.
Typical Deliverables
1
2
3
4
5
6
