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.
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.
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
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.
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.
Life Cycle Management
The dedicated BlueReg lifecycle management product supply team are experts in navigating post approval activities and supporting client partners to successfully manage all post approval activities.
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).
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.
Preparation, writing and redaction of clinical study reports
BlueReg can support you with a highly experienced team of professsionals in preparing and writing of your clinical study reports, supporting the redaction proposal and document package for submission to the EMA to comply with EMA policy 0070.
BlueReg will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.
Bluereg has extensive experience in writing safety documents and can support you with assessing a product’s risk benefit profile for your product.
Publishing & submissions
BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide. BlueReg provides a broad range of services for electronic Submissions (eSubmissions). You can rely on the BlueReg experienced team and efficient use of publishing and formatting tools to prepare your dossiers/documents according to Health Authority requirements.
Quality System and Audit
BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.
Pricing and reimbursement (Drugs and Medical devices)
BlueReg consultants can provide pricing and reimbursement insight and support you prior to the launch of your products in France. BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices).
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