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BlueReg Group https://stage-bluereg.fk-agency.net/ Pharmaceutical consulting for life sciences industry Mon, 19 Dec 2022 10:11:49 +0000 en-US hourly 1 Project Orbis https://stage-bluereg.fk-agency.net/papers/white-paper-project-orbis/ Mon, 19 Dec 2022 10:07:15 +0000 https://stage-bluereg.fk-agency.net/?p=41353 Download our white paper dedicated to Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries.

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]]> 5 Must-Knows About Paediatric Investigation Plan in the EU https://stage-bluereg.fk-agency.net/papers/5-must-knows-about-paediatric-investigation-plan-in-the-eu/ Thu, 08 Dec 2022 12:09:25 +0000 https://stage-bluereg.fk-agency.net/?p=41136 Download the 5 Must-Knows about Paediatric Investigation Plan in the EU   Why do we need an EU PIP? Is a PIP required ? Planning for the PIP procedure Overview of the PIP procedure 9 months to 1 year Content of the PIP Application

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]]> 10 key requirements to launch your medicinal product in the EU https://stage-bluereg.fk-agency.net/papers/10-key-requirements-to-launch-your-medicinal-product-in-the-eu/ Wed, 30 Nov 2022 10:04:20 +0000 https://stage-bluereg.fk-agency.net/?p=40809 Download the 10 key requirements to launch your medicinal product in the EU:   Local Representatives National Codes Blue Box Serialization Local Databases Local launch Date Notification Promotional Materials Educational Materials Local Wholesale Distribution Authorization (WDA) Shared Pack and Stock Keeping Unit

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]]> Guideline on Orphan Drugs for US Pharmaceutical Companies willing to enter the EU Market https://stage-bluereg.fk-agency.net/papers/guideline-on-orphan-drugs-for-us-pharmaceutical-companies-willing-to-enter-the-eu-market/ Mon, 28 Nov 2022 09:02:26 +0000 https://stage-bluereg.fk-agency.net/?p=40754 Download the Guideline on Orphan Drugs for US Pharmaceutical Companies willing to enter the EU Market:   Legal basis Guidance Advantages Eligibility Regulatory Procedure

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]]> 4 Tips for biotechs developing orphan drugs for the EU market https://stage-bluereg.fk-agency.net/papers/4-tips-for-biotechs-developing-orphan-drugs-for-the-eu-market/ Fri, 25 Nov 2022 09:04:27 +0000 https://stage-bluereg.fk-agency.net/?p=40564 Download the 4 tips for biotechs developing orphan drugs for the EU market:   Key facts about Orphan Medicinal Product (OMP) Regulation and Rare Diseases in the EU Cost and Incentives of OMPs Incentives & Orphands: A profitable market After Orphan Drug Designation – EU

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