BlueReg is your strategic partner to meet your 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.
- Regulatory and medical review and validation of all advertising and promotional materials at the global and local level with:
- One identified project manager as your central contact point and campaign oversight co-ordinating all worldwide activities with all stakeholders including KPIs & metrics to ensure high quality of deliverables as per agreed timelines.
- A BlueReg expert team dedicated to your products for the European/global review and validation of your materials.
- A worldwide network of local partners, providing the services of local signatories / person responsible as required in line with local requirements (e.g. The Association of the British Pharmaceutical Industry (ABPI) signatory in the United Kingdom, Information Officer (Informationsbeauftragter) in Germany, Regulatory Scientific Services in Italy and Responsible Pharmacist in France)
- Support on the full set up, training and validation of your procedures: write or review Standard Operating Procedures (SOPs) and working instructions on a global and national level.
- Provide advice on the software workflow for each market taking into account the local requirements for review, approval and signature of promotional items.
- Provide training on promotional material review and validation requirements for global or local requirements.
- Management of the review and validation of all types of promotional materials in local languages and in client systems such as Veeva®, Trackwise® and so on.
- Clear, concise market feedback provided on alternative options and risks associated with the promotional materials for decisions to be undertaken for each piece / market
- Submission of materials to regulatory agencies as required at a national level
Various types of materials
We manage material according to local market requirements but a broad list of applicable codes of practice include International Federation of Pharmaceutical Manufacturers and Associations (IFPMA code), WHO Resolution Ethical Criteria for Medicinal Drug Promotion, European Federation of Pharmaceutical Industries and Associations (EFPIA code), and local regulations such as the Association of the British Pharmaceutical Industry (ABPI code), French National Agency for the Safety of Medicines and Health Products (ANSM) recommendations, Medicines Australia Code of Conduct, the Brazilian National Health Surveillance Agency (ANVISA) and the Federal Food, Drug and Cosmetic Act or Medical Devices Laws.
Our clients range from start-ups to global pharmaceutical companies, requiring a temporary or permanent need for support with activities concerning promotional material review and validation.
BlueReg utilises experienced team members to review each material for compliance against international and local market specific codes / guidance. In addition, the expert reviewers provide further guidance based on their local experience to guide companies through the complex and diverse local requirements which are often challenging for global project teams to align campaigns and/or materials.
Clients rely on BlueReg’s regulatory intelligence as well as the experience and expertise of our consultants and partner network for the success of their projects. BlueReg can provide an end-to-end project plan to guide you through the regulatory preparation of the commercial product launch.
Review and assessment of a chatbot interactive tool available on an Internet website, among European regulations
A pharmaceutical company contacted BlueReg experts on promotional material for review of a non-promotional website...