Custom synthesis
of API from laboratory scale to pilot
scale for ‘out of patent’
APIs including synthon approach to chiral
molecules.
Pre-clinical studies
involving small animals both rodents and
non-rodents for safety and efficacy.
Formulation development
particularly for solid oral dosage forms,
both conventional and extended or modified
release. The formulation development will
include development on laboratory scale,
pilot scale and manufacturing scale including
packaging development.
The data shall be supported by the stability
studies conducted based on ICH guidelines,
analytical method development for the
formulations, the dissolution profiles
and complete documentation.
Clinical trials
Phase I studies in
Healthy human volunteers (BE/BA
studies)
Infants
and neonates
Small number of patients
Patients in hospitals
Clinical trials
Phase II to Phase III studies in patients.
Herbals & Nutraceuticals
Developing validated analytical
methods leading to standardization
of herbal drugs, Nutraceuticals and
their formulations using suitable
bio-markers
Conducting
BE/BA studies and Clinical trials
on herbal/ nutraceutical formulations
in modern and alternate systems of
medicine.
Education Courses
- Conducting short-term value addition
courses in clinical and other relevant
areas.
