We at HYS LifeCare has a team of SMART, dedicated experienced scientists who offer committed services in the areas of Discovery Research, New Drug Delivery Systems/Value Added Generics thereby transforming discoveries into the highest quality therapeutic products.
HYS LifeCare is committed to innovation by discovering new molecules and formulating unique therapeutic approaches.
HYS LifeCare is a pharmaceutical player in the field of complex generic medicines, who are also working in developing generics molecules rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of auto-immune/neurodegenerative diseases – particularly multiple sclerosis – oncology and veterinary sciences.
Our scientific team works closely with our marketing team to generate innovative concepts and ideas, exploiting both market needs and synergies across therapeutic areas
Analytical Method Development
Accurate and rugged analytical method is an essential part of pharmaceutical business. In addition to chemical and (bio) pharmaceutical R&D, we carry out analytical method development at our location at Ahmedabad. We have our own fully functional analytical method development unit. We have a team of scientists who can develop the methods on Raw Material, Semi Finished Goods and Finished Goods in all categories of drugs.
The combination of innovative R&D and proven human ability to manufacture and distribute high eminence pharmaceuticals positions us well for our future in specialty pharmaceuticals.
Analytical Method Validation
With reproducibility and every time accuracy in analytical method being an essential part of pharmaceutical business. The developed method crosses the stages analytical method validation as specified in US Pharmacopeia general chapter <1225>.
We carry out analytical method validation at our Quality Control laboratory.
HYS LifeCare provides complete stability testing and storage services for products at all major ICH conditions as well as custom conditions. We work with pre defined protocol and offer services from pre-clinical study supplies, clinical trial supplies to commercial manufacturing & commercial launch
Key Stability Studies
- Formulation prototype stability
- Pre-clinical and clinical stability
- Temperature excursion studies
- IND stability
- NDA stability
- ANDA stability
- Commercial stability
Prior to initiating stability study, we develop or conduct analytical method transfer/ method qualification to ensure that methods meet pre-defined specifications for intended end use/purposes.
We also generate stability protocols, generate and compile stability data, evaluate data, and prepare reports for regulatory submissions. Stability Storage
At HYS LifeCare, our cGMP stability storage facilities include 21 CFR part 11 compliant walk–in and reach–in chambers. Stability studies are routinely performed at various time-points under conditions of different temperature and humidity (real time, accelerated and stress studies as per ICH guidelines).
In addition to routine stability studies, various exploratory studies are also conducted, including:
- In-use stability
- Hold-time stability
- Shear stress
- Container and closure
- Comparator studies