Medical and Regulatory Writing

Clinox realizes the need for high quality submissions to Regulatory Authorities and Ethics Committees to ascertain timely approvals.

Our team of experts have adequate experience in completing the most challenging Regulatory Authority and Ethics Committee submissions. Awareness of such intricacies helps us to further write the best-in-class documentations for your study.

You can rely on Clinox with all your medical and regulatory writing to obtain an expert approach in your documents.

Review of site facility, resources, source documentation practices, EC’s SOP etc. and up-scaling (as and where required) to meet the ICH-GCP and applicable regulatory requirements (Schedule-Y).

Identification and development of potential Principal Investigator(s) (PIs)

Assistance in the execution of Undertaking by the Investigator (Appendix-VII of Schedule-Y), Form FDA 1572, Financial Disclosure, Clinical Trial Agreement etc.

Communication with study Sponsor/CRO

Translation and validation of ICF in required vernacular language(s).