Clinical Trial

• Protocol Development –Pre and Clinical
• Assessment of Best Hospitals and Trial center
• Ethical Committee Registration
• CTRI registration
• Assessment of protocol in consultation with FDA technical personnel
• Assessment of technical requirement for preparation of Drug Master File and CTD for all categories of Pharmaceutical products in order to minimize deficiency in filing.
• Guidance and filing of Recombinant product and Vaccine and co-ordination with other approving and technical authority like ICMR, DBT, RCGM and NIB, Noida and NIV, Pune and AIIMS.
• Service for Clinical Trial co-ordination in major cities like Delhi, Kolkata, Hyderabad , Mumbai, Bangalore , Chennai, Ahmadabad, Bhubaneshwar.