Insuvia provides a one-stop solution to pharmaceutical companies looking to build up a regulatory dossier from scratch. That is why we assure you – we carry out our work in a timely and high-quality manner with the help of our highly qualified field experts.
Our medical writing and regulatory affairs teams prepare documents required to support the applications at all stages of product lifecycle in compliance with applicable regulations and standards, ensuring that the efficacy, safety and quality of your medicinal product is demonstrated properly.
We can help with full development and formatting of your regulatory dossier to be submission ready:
Development of Non-clinical Overview/Summary (Modules 2.4/2.6)
Development of Clinical Overview/Summary (Modules 2.5/2.7)
Development of Quality Overall Summaries (Module 2.3)
Preparation of Addendums to Clinical Overview
Development of Summaries of product characteristics (SPCs) and Package Leaflets (PL)
Package Leaflet Readability User Testing (RUT) or Bridging Reports (Module 1.3.4)
eCTD publishing activities using a fully validated system
Risk Management Plans (1.8.2)
You may also be interested in:
Marketing Authorization Applications
Regulatory strategy and marketing authorization services aimed to achieve fast and smooth regulatory approvals.
Read moreQPPV & Pharmacovigilance System
Global pharmacovigilance system, including all pharmacovigilance processes and activities to assure compliance and patient safety.
Read moreLocal Regulatory Affairs Outsourcing
Local regulatory support to assure regulatory compliance and maintain licences through product life-cycle.
Read more