Regulatory Affairs
We understand that regulatory affairs are an important part of clinical research, so we make your life easier by handling all of your regulatory affairs needs. Based on our knowledge of Indian regulatory frameworks and expertise, applications are approved quickly in India. We can support you in obtaining regulatory approval for your protocols and dossiers more quickly.
Our ability to handle regulatory services include:
- Creation and filing of regulatory dossiers for clearance of clinical trials and marketing authorizations.
- Constant Communication with Regulatory agencies for Filing and Clearance.
- Protocol presentation to Subject Expert Committee.
- Import & export Permits for Investigational Products (IPs), Biological Samples, Associated Materials, and Medical Instruments (If any).
- Clinical Trials registration in National Registries like CTRI in case of India.
- National / Local Ethics Committee/IRB approvals.
- Safety Reporting: SAE, Annual Reports and Safety Reports.