The role of affiliates is changing. As a result, more and more pharmaceutical companies expect their affiliates to focus on commercial activities. Because of this, the regulatory part becomes integrated into global departments. Within this changing model, insuvia acts as the local regulatory affairs unit for pharmaceutical company affiliates and/or corporate teams.

As a company we pride ourselves in providing exceptional customer service which is delivered by best-in-class local experts. They stand out with intimate knowledge of local regulations and best practices through each country of our presence.

Our team approach to local regulatory affairs service is built around a commercially-minded organization culture. Due to this, we support not only the technical aspects of regulatory affairs but as well as communicate and work closely with the customers and their affiliates to understand their commercial business needs and expectations on all levels. Knowing their needs and expectations we align our operations and set priorities aiming towards our customer’s commercial goals.

Insuvia provides comprehensive local regulatory affairs services :

  • Input on regulatory strategy, including scientific advice meetings with national Health Authorities 

  • Dossier gap-assessment and due diligence from local regulatory affairs perspective 

  • Point of contact with national Health Authorities 

  • Submission compilation, incl. all national documents (cover letters, application forms, fees payment, etc.) 

  • Local regulatory life-cycle management which includes submission and execution of national applications.

  • Handling of responses to questions from local authorities and liaison with assessors until approval is granted 

  • Translationfor all procedures, e.g. product information, artwork, approval letters, and etc.

  • Provision of information on national Health Authorities websites and databases 

  • Business reporting and notifications to local Health Authorities: 

  • Regulatory intelligence and legislation monitoring with constant updates to the customer 

  • Assistance and provision of necessary documents during audits and inspections of affiliates 

  • Artwork review, updates and change requests based on labelling changes 

Discover our PV and Regulatory Affairs services:

Country-level pharmacovigilance systems and local QPPVs to assure safety compliance in individual countries.
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Regulatory strategy and marketing authorization services aimed to achieve fast and smooth regulatory approvals.
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Medical writing and Dossier development services covering all documents from Module 1 to Module 5.
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