The dedicated BlueReg lifecycle management team are experts in navigating post approval activities and supporting client partners to successfully manage all post approval activities.
The worldwide marketplace presents a variety of challenges, from numerous official working languages to varying and complex regulatory systems and requirements. With the knowledge and expertise of our expert regulatory teams, we can design, implement, and run the post approval activity for your product.
We manage these activities using our Outsourcing Platform on Post-Authorisation Regulatory Services “OPPARS”. This is a proven way in which the client can benefit from a timely ramp up of services in the required markets.
Given the exposure BlueReg have in different approaches to lifecycle management we can advise on best practice, use our experience and knowledge to help setup infrastructure and organisations to cope with the full range of post approval activities. This management consultancy approach is built on years of experience in the pharmaceutical industry and in outsourcing support.
BlueReg is the strategic partner to meet client goals for post approval support for drugs and medical devices.
BlueReg provide a broad range of services linked to lifecycle management. These flexible solutions range from an integrated package of outsourced services to adapted ad-hoc regulatory and technical support. Our goal is to ensure you have the service tailored to your specific needs and provide relevant advice to ensure you maintain your competitiveness in this complex and changing regulatory environment.
BlueReg also manage compliance projects in Chemistry Manufacturing and controls (CMC) and/or product labelling. Our teams have experience in large and small pharmaceutical and medical device companies and have managed global compliance activity.
BlueReg can help you to meet your goals in all types of post-authorisation activities for your medicinal products, drugs and biologics, registered worldwide.”
Support and services
Clients rely on our regulatory intelligence as well as the experience and expertise of our consultants for the success of their project. BlueReg can provide you with an end-to-end project plan to guide you through post authorisation and beyond. Some of the services we offer include:
- All types of variations (administrative, safety, CMC etc.), renewals, license transfers, and management of post-approval commitments
- Advice on variation classification and local requirements such as European grouping / super grouping and work-sharing procedures
- Advice on life cycle management in the US including annual product reviews, and amendments
- CMC and safety compliance: gap analysis undertaken between approved dossier components and manufacturing / source reference documents. Provision of regulatory strategy to upgrade the corresponding part of the dossier
- Strategic Advice for line extensions, legal switch applications and inform consent submissions
- Support for the process of linguistic review and other translations
- Support with local launch preparation
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
Quality System and Audit
BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.
Advanced Therapy Medicinal Product (ATMP)
Looking for an Advanced Therapy Medicinal Product (ATMP) classification? BlueReg can guide you to submit a classification application to Health Authorities to determine if your product meets the requirements to be defined as an ATMP.
Product Quality Review
BlueReg has an experienced team for Product Quality Review (PQR) writing including CMC, Quality and Regulatory Affairs consultants dedicated to supporting your company through PQR reviews for your medicinal products.
Market Access 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) in France.
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.
Early & Expanded Access Programs in France
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs projects in France .
Support for the preparation and submission of Marketing Authorisation Transfer Applications in over 20 European countries
BlueReg was engaged to assist a biopharmaceutical company based in France with the preparation and the submission of transfer of...Download now