New MAA & Product Approval

New Marketing Authorization Applications (MAA) are associated with considerable time and cost. Choosing the right regulatory strategy and optimal application route, as well as to assuring that the dossiers are accurate and compliant, shall help achieve faster product approval, save time and cost.

Insuvia team has extensive experience in the submission preparation and approval obtainment for over 50 new MAAs in various countries. Our team can help navigate you through the regulatory process and bring products to market as efficiently and fast as possible.

Services Offered:

EMA and National Scientific Advice procedures

Regulatory Strategy

Dossier Gap Analysis

eCTD publishing

Submission and Procedure Management

Liaison with Health Authorities

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MAA procedures handled
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Countries covered
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eCTD sequences each year

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Nov 04, 2021

Regulatory Affairs Outsourcing Considerations

The pharmaceutical market is rapidly evolving and changing. Many pharmaceutical companies are…

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Jan 11, 2022

Marketing Authorization Transfer Considerations

Overview The high level of Mergers and Acquisitions (M&A) reflects the incredibly…

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Aug 03, 2020

Bringing the Dossiers into Compliance in the EAEU

Until December 31, 2025, the Eurasian Economic Union (EAEU) which consists of…