The BlueReg team can help meet your goals in all types of post-authorisation activities for your medicinal products worldwide.
Our team can assist you with :
- All types of variations (administrative, safety, chemistry manufacturing and controls (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
- 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 and legal switch applications and informed consent submissions
- Support for the process of linguistic review and other translations
- Support with local launch preparation
BlueReg supports various companies with their post-approval activities: such as pharmaceutical companies who want to outsource post-approval activities to focus their internal resource on development projects or those who do not have the regulatory expertise or a local representative in the EU or Rest of the World (RoW).
BlueReg provides strategic advice and operational support utilising our consultants which have significant industry experience in lifecycle management and liaising with the regulatory agencies (EU and RoW).
In all these activities, BlueReg will :
– Provide a dedicated team of BlueReg consultants highly experienced in post-authorisation activities
– Ensure project management oversight to maintain consistency and high quality
– Share the BlueReg best practice guide and integration kit to ensure that all team members have access to the same information
– Put in place a robust regulatory intelligence process to ensure compliance with the national regulatory requirements
– Be involved at every stage of your projects:
- Writing administrative, CMC, nonclinical and clinical Common Technical Documents (CTD)
- Compiling CTD dossiers as per local requirements
- Ensuring publishing according to local requirements
– Develop processes and Key Performance Indicators (KPIs) for continuous monitoring
– Propose a quality assurance plan and maintain adequate transition between every project stage
BlueReg experts : BlueReg has dedicated regulatory consultants, highly experienced in all post-authorisation activities, providing flexible solutions to support your full requirements. No matter how complex your requirements are, BlueReg experts can help you to design the appropriate support you need
Safety and / or CMC compliance project High-level Approach
– Assign a dedicated compliance team
- Review reference documents such as Core Data Sheet (CDS), Company Core Data Sheet (CCDS), Summary of Product Characteristics (SmPC) / United States Prescribing Information (USPI) against the current guidelines
- Upgrade reference documents accordingly and compile gap analysis against the local SmPC/USPI
- Develop regulatory strategy to locally implement reference texts in your local SmPC/USPI
- Review all registered CMC dossiers against technical records and reports from the manufacturing sites
- Develop appropriate strategy to upgrade CMC dossiers
- Prepare and submit the corresponding variation(s), updated module 3 sections and Quality Overall Summary (QOS) as per local regulations
– Launch a geographical roll out of corresponding variations / notifications (preparation and submission)
- Follow up until local implementation complete
EMA GUIDANCE – COVID-19
Given the support given to our clients in interactions with health authorities all around the...
News - 23 April 2020
Nitrosamine impurities – are you ready to fulfil your legal obligations as a MAH by March 26th, 2020?
During the summer 2018, authorities become aware of the presence of some nitrosamines in API...
News - 12 February 2020