- Through the hands-on expertise and the leadership of our team, advisory board, medical experts and research analysts we will help you to align the clinical development of the molecule.
- Identification of critical issues, actions and implication through safety and competitive Intelligence, for example, competitor analysis, competitor program to treat potential recruitment etc
– Clinical Pharmacology strategy
– SAD and MAD studies
– Proof of Concept strategy
– Development strategy for each indication
– Indications integration strategy based on regulatory strategy
– Biomarker development strategy
– India specific strategy ( regulatory, ethnicity etc)
– Advisory services on post approval commitments
– Safety and risk management strategy
– Center of excellence supports execution of your Translational Medicine/Clinical Pharmacology Research programs
‘Outsource us as a package, we deliver it by ourselves or by audited partners.Save your time. Save your money.’
Preclinical/Non-clinical Development Stage
- Animal Toxicology studies to support regulatory filing*
- Development DMPK studies to support regulatory filing*
- Regulated Bioanalysis to support animal toxicology studies
- Immunogenicity for PD and safety assessment*
- Biomarkers for animal pharmacology studies*
- PK/TK modeling
Clinical Development Stage
- Phase 1 Healthy Volunteer studies
- Phase 2 to 4 Patient studies
- Development DMPK studies to support NDA filing
- Regulated Bioanalysis to support clinical studies
- Immunogenicity for efficacy and safety monitoring*
- PGx for patient stratification and efficacy monitoring
- Biomarkers for efficacy and safety monitoring*
- Clinical PK/PD modeling
* Actual conduct of studies in GLP environment are conducted at partner sites