BE/BA Services

SK PHARMA INTERNATIONAL offers high level Technical, Project Management, Monitoring and Auditing of BA/BE Studies including:

Project contract, budgeting and negotiation
Time management from protocol design to report submission.
Protocol synopsis, review of protocol, Project initiation and in-study monitoring.
Site Selection/Qualification Visits
Site Initiation Visits
On-Site Monitoring Visits
Site Closure Visits
Remote Monitoring
Technical discussion
Timely update to sponsors about the study progress
Bio-analytical Monitoring
Regulatory Affairs (DCGI submission, BE NOC and T- License)

We can take complete sponsorship on behalf sponsor in the execution of BA/BE studies.