Regulatory Affairs and Medical writing
Performing volunteer clinical study
Presenting SEC meeting for different sponsors
Preparation of CT and BA/BE study protocols
Communication with EC for approvals
Communication with sponsors to fulfill technical requirements
Preparation and maintenance of volunteer pool
Maintenance of SOP
Conducting of GCP training every year in accordance to fulfill the regulatory requirements
Performing DCGI and ISO audits as required
Volunteers Clinical Phases coordination and CPU Management
We have carried out Clinical studies successfully even in COVID time.
The regulatory team has successfully conducted volunteer run in presence of different sponsors including Hetero, Neon Pharma.
We have modified our CPU facility and all requirements to satisfy regulatory requirements according to CDSCO guidelines.
We have acquired fire license as a essential component for CPU facility, suggested by DCGI.
We are maintaining proper documentation for volunteer log, and biometrics of volunteer to avoid cross participation.
SEC Meeting
Our regulatory team have presented over 100 SEC meetings with minimum failure.
We have partnered in SEC meetings on behalf of several companies, like: Akums, Micro labs, USV, Lincon pharma, Optimus pharma, Pulse pharma and so on.
We have presented BE study protocol, BE study report, CT waiver presentation and so on.
Accolades
