21.0 Post marketing surveillance data (vigilance reporting): The dossier should conta ...

7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstr ...

All relevant clinical and non-clinical safety data will cover only the period of the ...

Other information: This section of PSUR shall include details about signals and Risk ...

Other information: This section of PSUR shall include details about signals and Risk ...

Monitoring plan General outline of the monitoring plan to be followed, including acce ...

Top management of the manufacturer shall ensure that responsibilities and authorities ...

Accredited Consultants Pvt. Ltd. The might be involved in pharmaceutical licensing or ...