Product Quality Reviews
BlueReg has an experienced team for Product Quality Review (PQR) writing including Chemistry Manufacturing and Controls, Quality and Regulatory Affairs consultants dedicated to supporting your company through PQR reviews for your medicinal products
From data gathering, through data analysis and PQR writing, we provide flexible solutions to meet your company’s requirements
PQR is a regulatory requirement (EU-GMP chap 8, US 21 CFR part211, and ICHQ7A) and an effective quality improvement tool to verify the consistency of the existing process and overall quality of the product, to be conducted annually. These PQRs are assessed thoroughly by inspectors during Health Authority inspections and should be carefully managed by trained and knowledgeable staff.
BlueReg can fully support to set up the PQR process in your company and/or manage your annual reviews. Our experienced team utilise the following approach which can be tailored to your specific needs:
- Manufacturer PQR
- Local data (variations, deviations, contracts, complaints and recalls)
- Compliance to Good Manufacturing Practice (GMP) requirements
- Critical review of batch data evaluation performed by the manufacturer
- Evaluation of the overall quality of the product
- Assessment of the consistency of the existing manufacturing process
- Highlight of any trends
- Review of the proposed Corrective Action Preventive Actions (CAPAs), highlighting action plans to be monitored or added
- Verification of the consistency between local data and information provided by the manufacturer
Writing the PQR for the « Exploitant »
- Writing in accordance with the client or BlueReg template
- Assessing manufacturing results and setting conclusions on process control
- Providing a global assessment on the local data and the evaluation undertaken by the manufacturer
The BlueReg team have a highly successful track record of delivering all French market specific services, from the simple to the complex providing expert advice as well as hands-on operational support..
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
Looking for help and support in entering the UK? Our UK based consultants can provide support and advice for all your project requirements in relation to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Looking for help with regulatory activities in the United States? BlueReg can help to navigate the Food and Drug Administration (FDA) regulations and provide support and advice for all your project requirements.
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).
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 assists companies to plan and submit any necessary changes to existing marketing authorizations before the end of the Brexit transition period in order to comply with EU law. Please contact us or follow our BlueReg Linkedin page to be kept up to date with the Medicines and Healthcare products Regulatory Agency (MHRA) Brexit guidance as they are issued.
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 can assist with all your audit requirements and can provide a complete audit preparation package which we can tailor to your needs.
Specific Services for Europe
BlueReg has a dedicated team who cover the whole development process from concept to approval, on centralized or multi-national projects. Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.
Early Access Programmes (ATU)
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 (ATU) projects (nominative and cohort) 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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