Stability Program


We offer Stability Study Services to support all phases of Product Development


1.Pre clinical Stability programs

These studies begin with pre clinical phase to support animal toxicology.

2.Phase I stability programs

In Phase I, studies are used to establish drug/ excipient compatibility to assist in formulation development and ensure the stability of the API as formulated in the Clinical Trial Material (CTM).



3.Accelerated / stressed stability to support early specifications

In Phase I, studies are used to establish drug/ excipient compatibility to assist in formulation development and ensure the stability of the API as formulated in the Clinical Trial Material (CTM).

4. Phase II and Phase III stability programs

These studies are conducted on the drug substance, and drug product and comparators during clinical trials.


5.Late Development stability programs to support final specifications and shelf Life

These programs form the basis for understanding degradation kinetics and therefore provide scientific rational for the final specifications and shelf-life.

6.Registration Stability for NDA / MAA fillings

Most importantly, these studies are performed on manufacturing scale-up and/or process validation batches, and registration batches in final formulation and packaging for New Drug Application ( NDA / MAA ) fillings.


7. Marketed Product Stability to ensure commercial quality control

Phase IV, marketed product stability studies are conducted to ensure commercial Quality Control.

8.Stability studies to support scale-up and Post approval changes in existing process

Scale-Up and Post Approval Changes (SUPAC) and Product Life Cycle Management (PLCM) stability studies are used to support changes in the existing process and new dosage forms, delivery systems, and changes in packaging.



Let's Get In Touch!


Ready to start your next project with us? That's great! Give us a call or send us an email and we will get back to you as soon as possible!

+91 80 41250324