Marketing Authorization Applications and Regulatory services

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.)

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

Discover our Pharmacovigilance and Regulatory solutions:

Local Regulatory Affairs Outsourcing

Regulatory Dossier Writing

QPPV & Pharmacovigilance System