Vakils’ Value Added Services: Regulatory and Artwork Integration Processes

All medicines must receive authorisation before they can be marketed and made available to patients. In the European Union, there are two main routes for authorising medicines (centralised route and national route).

Value-added services (VAS) for pharmaceutical artworks are services that go beyond the basic creation and delivery of artwork. VAS can be used to improve the efficiency and effectiveness of the artwork process, reduce costs, and ensure compliance with all applicable regulations.

Vakils offers unique artwork management and regulatory services, which covers European Union Centralised Packs and General Export Packs (GEXPs). Our team connects with the Product Therapy Groups (TGs) and regulatory databases to understand product submission processes and approval dates.

We review regulatory documents (global data sheets and labelling annexes) for safety and site technical changes. Our experts understand the changes from a regulatory perspective and implement the pharmaceutical packaging components. We are capable of handling variation updates on behalf of our clients.

Vakils’ team is able to understand regulatory documents (Global Data Sheet (IPI) and European Labelling Annexes (III). We notify the artwork and safety changes to the artwork vendors. Our team coordinator is able to plan product launches, priority variations (safety changes) and bundling variations to save the cost as per implementation time.

These value added services improve communication and collaboration between the different stakeholders involved in the artwork process. By offering these services, we help pharmaceutical companies to improve the efficiency and effectiveness of their artwork process, reduce costs, and ensure compliance with all applicable regulations.

Reach out to us at info@vakilspremedia.com for more information on our value added services.