Advertising & Promotional Material Review
BlueReg is well known for Advertising and Promotional copy review during and after the launch phase. We provide experts in their field, well used to managing local codes of practice and managing activity in local language and in client systems such as Veeva®, Trackwise® and so on. We manage and coordinate activity to ensure a consistent approach across markets so that a practical level of feedback is provided and in a consistent manner.
We manage all this activity using our Outsourcing Platform on Promotional Material Services “OPPROS”. This is a proven way in which client can benefit from a timely ramp in services in which ever market they require.
We manage all manner of materials in any format. This includes website reviews, leave pieces, educational material, and sales education material.
Time to engage with BlueReg
As an outsourcing and consulting services company, BlueReg is the strategic partner to meet client goals for worldwide promotional material review and validation for drugs and medical devices.
We provide a broad range of services linked to the review of promotional material for international congresses and local compliance. These flexible solutions range from an integrated package of services to adapted ad-hoc regulatory and technical support. Our goal is to explore innovative approaches and provide relevant advice to ensure you maintain your competitiveness in this complex and changing regulatory environment.
We manage material according to local market requirements but a broad list of application codes of practice include IFPMA code, WHO Resolution Ethical Criteria for Medicinal Drug Promotion, EFPIA code, Medical Device Regulation 2017/745 and local regulations such as ABPI code, ANSM recommendations, Medicines Australia Code of Conduct, ANVISA resolutions, Federal Food, Drug and Cosmetic Act ….
Typical review processes and responsibilities include the following:
- Consistent with locally approved prescribing information where it includes benefit claims for the medicine.
- Promotional information considers the context and intent of information in the approved label, and statements from the label may not be reproduced out of context.
- Clear, legible, up to date, accurate, fair, objective and balanced.
- Capable of substantiation (verifiable).
- Based on relevant evidence and sufficiently complete to enable the recipient is able to form her/his own opinion of the medicine.
Services and support
Clients rely on our regulatory intelligence as well as the experience and expertise of our consultants for the success of their project. We can provide you with an end-to-end project plan to guide you from registration strategy through to authorisation and beyond. Some of the services we offer include:
- Regulatory, medical & legal review and validation of promotional materials at a global and local level :
- Ensure a complete worldwide coordination with a project manager as your central contact point
- With our worldwide network of local partners, provide services of local signatories as per local requirements (e.g. ABPI signatory in the United Kingdom, Information Officer in Germany, Regulatory Scientific Services in Italy, Responsible Pharmacist in France…)
- Write, review and revise quality package documents at global or local level (SOP, validation forms, working instructions…)
- Provide advice on the validation workflow, through the choice, configuration and implementation of an adapted software along with the writing and review of related SOPs
- Provide training on promotional material review and validation requirements (e.g. for global or local requirements)