Our Services
Clinical Trials
We support Sponsors and CROs in bringing innovative drugs to market safely and effectively.
Trial Planning and Design: A detailed trial plan implemented to achieve specific expectations and regulatory specifications.
Regulatory Proposals & Approvals: Ensuring adherence to national and international laws to facilitate successful approval procedures.
Site Management: Effective execution and maintenance of trial sites in order to ensure outstanding results.
Patient Recruitment & Retention: Methodologies for recruiting and keeping participants, thus decreasing dropout rates.
Data Management & Monitoring: Precise collection of data, evaluation, and assessment to produce excellent outcomes.
Safety & Risk Management: In order to ensure participant safety, risk factors are promptly detected and prevented.
Project Management: Highly skilled leadership to assure that trials have concluded within deadline and budget.
Close-Out & Reporting: Precise reporting for regulatory submissions and highly organized close-out activities.
Regulatory Affairs
We provide expert regulatory support for clinical studies and medical device registration.
- US FDA
- WHO
- ICMR
- DCGI
- EMA & CDSCO
- CTRI
Quality Assurance
- ICH-GCP (E6) R3
- CTCAE
- ALCOA+ Principles
- NDCT Rules 2019
Our Partners
- Sponsors
- CROs
- Hospitals & Investigators
- NABL Laboratories
- Biomedical Companies