Promotional Materials

We provide promotional materials regulatory review services to assure compliance with local country-specific regulations and pharmaceutical product marketing codes.

Our regulatory experts provide clear and constructive feedback on each promotional material indicating associated risks and potential solutions to overcome them. When it comes to promotional materials and activities, our aim is to ensure that the result is both compliant, as well as effective and appealing to the target audience.

Our comprehensive local regulatory intelligence process guarantees that we continuously remain up to date with the national legislation, marketing and advertising guidelines and local ethical codes.

Our promotional material regulatory review services cover all EU member states and CIS countries. We have experience with multiple promotional material review and approval tools, such as Veeva Vault PromoMats and ZINC.

Services Offered:

Regulatory review of promotional materials and non-promotional materials and activities

Creation of Abbreviated Product Information (API) texts

Submission of materials to national regulatory authorities where required or possible at a national level

Translation of promotional materials to local languages

Set-up of processes (e.g. SOPs, IT systems, etc.) for review of promotional materials

Promotional-material archiving and data management

Consultancy on advertising and promotional material requirements

Training for the client teams (e.g. commercial department) on advertising and promotional material requirements

Countries covered
Promotional materials reviewed per year
Local regulatory experts

Read more

Nov 04, 2021

Regulatory Affairs Outsourcing Considerations

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

Read more

Jan 11, 2022

Marketing Authorization Transfer Considerations

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

Read more

Feb 25, 2022

Requirements for Nomination of a PV Contact Person

Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders…