Outsourcing Platform on Promotional Material Services “OPPROS”
BlueReg is the 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:
- Clear, concise market feedback provided on alternative options and risks associated with the promotional materials for decisions to be undertaken for each piece / market
- 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)
- Submission of materials to regulatory agencies as required at a national level
- One identified project manager as your central contact point and campaign oversight co-ordinating all worldwide activities
- In addition, BlueReg can support throughout 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
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), Medical Device Regulation 2017/745 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.
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.
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 provide expertise in registration strategy in the US or in Europe, provide manpower to produce high quality registration dossiers using our multidisciplinary team of regulatory affairs, scientific writing, and publishing, and manage submission process through to a satisfactory conclusion
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
Advertising & Promotional Material Review
BlueReg is the 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.
Drug Registration and Regulatory Roadmap
BlueReg can be your preferred partner to support the registration of your medicinal product in Europe, in the US or in other worldwide countries. Our team of experts can also facilitate and guide clients through the process of formulating the roadmap, provide critical review of one or more elements of the roadmap, or provide hands on operational support through authoring some or all the components.
Looking for peace of mind with outsourcing your regulatory projects and/or activities? BlueReg provides a tailored service with a continual monitoring and partnering with our experienced project managers to ensure a high quality of deliverables as per KPIs and metrics agreed at project initiation.
Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorisation (MA).
Looking for support of small to medium enterprise (SME) status in the European Union? BlueReg coordinates SME client status dossier preparation and submission through its experienced project management team. BlueReg can also optimise the application content to expedite the approval by EMA.
Searching to Outsource Post Authorisation activities?
BlueReg can help with all post-authorization activities for your medicinal products worldwide.
BlueReg is your strategic partner to meet your goals for all medicinal product registrations worldwide. BlueReg provides comprehensive regulatory affairs services, in global regulations and intelligence, across all regions of the world
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.
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