New Marketing Authorization Applications are associated with considerable time and cost. We help our clients to choose the right regulatory strategy, optimal application route, as well as assure compliant and accurate dossiers. This ultimately results in faster marketing approvals and saves our clients time and cost.

Insuvia has extensive experience in the submission preparation and approval obtainent for over 50 MAs in various countries. We utilize our expertise and extensive local network with established health authority connections to help navigate you through the regulatory process and also bring products to market as efficiently as possible.  

Marketing Authorization Applications – from regulatory strategy and dossier preparation, to full procedure management and liaison with the assessors until approval is granted:

  • Evaluation to determine the appropriate regulatory procedure and legal status  

  • Arrangement and management of scientific advice meetings with regulatory authorities  

  • Planning of optimal filing and regulatory submission strategies 

  • Dossier gap-analysis and updates 

  • Dossier adaptation to local requirements  

  • Submissions & full procedure management (DCP/MRP or National Procedures) 

  • Liaison with the assessors until approval is granted and responses to questions from authorities 

  • National phase management and product information translations to local languages 

  • eCTD publishing activities using a fully validated system 

  • Assistance with audits and inspections 

  • Management of sample shipments/logistics 

  • Product life-cycle maintenance (renewals, variations, Rx to OTC switches, line extensions, etc.) 

Discover our Pharmacovigilance and Regulatory solutions:

Local regulatory support to assure regulatory compliance and maintain licences through product life-cycle.
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Medical writing and Dossier development services covering all documents from Module 1 to Module 5.
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Global pharmacovigilance system, including all pharmacovigilance processes and activities to assure compliance and patient safety.
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