At Catalyst, regulatory experts can quickly
identify potential regulatory requirements to meet the local regulatory
challenges. Our experts can determine current attitudes of regulatory
agencies to predict issues that are likely to come out enabling swift
approval of clinical trials.
From the preparation of dossier as per the
DCGI recommendations to the preparation of safety reports and clinical
study reports, we ensure regulatory compliance at every step
of the project lifecycle.
Services
Dossier Preparation
Liaison with MOH for Trial approvals, Import license etc.
Export license for the shipment of biological samples