About 25% of cancer deaths are from rare cancers. That is a staggering number. Explore the regulatory programs available to expedite much-needed treatments: https://bit.ly/3PxNAjj #Oncology #RareDiseases
Premier Consulting
生物技术研究
Morrisville，North Carolina 8,723 位关注者
Helping innovators transform life-changing ideas and breakthrough science into new medical treatments.
关于我们
Premier Consulting is a strategic product development and global regulatory consulting brand dedicated to supporting the specialized needs of emerging biotech, MedTech, and specialty pharma companies. These small to midsize companies are the very heart of drug development. Like them, we are dedicated to the patient journey and are driven by the challenges of bringing new life-saving technologies to market. Informed by our core capabilities, we deliver end-to-end strategy, regulatory, nonclinical, CMC, quality, and commercial solutions that are best in class. With a customer-centric culture, we couple efficiency with quality as we guide sponsors every step of the way to commercialization. We tailor development plans to meet the most rigorous global regulatory requirements and deliver results for sponsors - and the patients they serve. Premier Consulting is a business unit of Premier Research.
- 网站
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https://premierconsulting.com/
Premier Consulting的外部链接
- 所属行业
- 生物技术研究
- 规模
- 51-200 人
- 总部
- Morrisville，North Carolina
- 类型
- 私人持股
地点
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主要
获取路线
3800 Paramount Pkwy
US，North Carolina，Morrisville，27560
Premier Consulting员工
动态
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Even in the race to expedite life-saving drugs, quality is never compromised. Learn about process validation's role in ODD, BTD, & PRIME pathways and how it’s done concurrently with commercial manufacturing in our new blog: https://bit.ly/418H4Wd #DrugDevelopment #RegulatoryStrategy #ConcurrentValidation
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When we talk about valuing the patient journey, we mean it. Learn how to truly design patient-centric trials – even for the unique rare disease patient: https://bit.ly/3J74nno #RareDisease #RareDiseaseTrials #PatientCentricity #PatientsFirst #ClinicalTrials
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We’re getting the 411 on ONTs: The FDA has announced the availability of a draft guidance with recommendations on approaches for the #nonclinical safety evaluation of oligonucleotide-based therapeutics: https://bit.ly/3ZhgzMA #ONTs #FDANews #Oligonucleotides
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The prevalence of respiratory diseases continues to rise, making inhaled combination products more critical than ever. From a CMC perspective however, these are complex to develop. Learn more in our latest blog: https://bit.ly/48V0RKk #CMC #InhaledCombinationProducts #RespiratoryDiseases
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ACT brings together the great minds of #toxicology. Come meet our leaders on the topic at Booth #510! You’ll walk away with advice, insights, and you can win a Yeti – doesn’t get better than that! https://bit.ly/3NQ5mMJ Great work, Team! William Salminen, PhD, DABT, RAC, PMP, Rosanne D'Alessio #ACTOX2024 #DrugDevelopment #MedicalResearch
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For gene therapy to transform lives, every detail counts – like analytical testing. From identity and purity to potency and safety, these tests help make sure therapies meet FDA standards. And expert guidance can get you there: https://bit.ly/3xHGVMM #GeneTherapy #AnalyticalTesting #FDACompliance
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Streamlining IND-enabling nonclinical/toxicology studies – we can help with that. Stop by Booth #2500 at ACT to learn how. William Salminen, PhD, DABT, RAC, PMP and Rosanne D'Alessio will be there to answer all of your questions! https://bit.ly/3NQ5mMJ #ACTOX2024 #Toxicology
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New blog alert! We convened a panel of national payer pharmacy decision-makers... What’d we find out? See what they say about evaluating 505(b)(2)s and if an approved FDA label is enough to secure strong payer market access: https://bit.ly/3URgz3n Thank you, Will Bainbridge for this informative piece! #DrugDevelopment #DrugDevelopmentPathways #MarketAccess
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Say you have to conduct a randomized controlled trial. What happens if a placebo control is unethical or neither an active control nor standard of care exists? In silico trials! Lucky you, we have a guide: https://bit.ly/3FzYr6M #ClinicalResearch #ClinicalDevelopment #InSilicoModeling #InSilicoClinicalTrials
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