Regulatory setbacks and manufacturing inefficiencies can stall drug development, costing valuable time and resources. A proactive approach to Chemistry, Manufacturing, and Controls (CMC) is essential to stay ahead. DSI’s CMC HealthChek provides a structured gap analysis and risk assessment to identify weaknesses, mitigate risks, and align your program with regulatory expectations. From process development to commercial readiness, our experts help ensure a seamless pathway to approval. Discover how CMC HealthChek can support your program: https://lnkd.in/ejKvaTqb #DSI #CMCHealthChek #RegulatoryCompliance #PharmaDevelopment #Biotech #GAPAnalysis
DSI - DS InPharmatics, a PLG company
商务咨询服务
Harleysville，PA 4,745 位关注者
a ProductLife Company offering end-to-end CMC, QA, and Regulatory Services. We solve your drug development obstacles.
关于我们
In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group. Our merger with PLG will harness our combined strengths, offering our clients on both sides of the Atlantic support with their developed drugs approvals and post-approvals compliance, plus advisory services on the best market strategies to deliver a rapid ROI on their development. Together we will offer our clients increased pharmacovigilance capabilities - including a QPPV; pharmacovigilance consulting; and a fully validated safety database – as well as complementary toxicology-related services; RIM/electronic document management services; and support for medical device regulatory requirements. We see enormous potential in this new chapter for DSI and for you, our clients. As a PLG company, we have the opportunity to become part of a global force in life sciences regulatory and compliance solutions and services, and we’re incredibly excited to add our momentum to that effort. DS InPharmatics (DSI) offers one-stop, full-service CMC consulting resources to emerging pharmaceutical and biopharmaceutical companies. The exceptional value DS InPharmatics offers begins with our dedicated, multidisciplinary teams of manufacturing, quality, and regulatory affairs specialists. Our CMC consultants combine in-depth technical knowledge of product development with risk-based submission content and regulatory strategies for all phases of the review and approval process. This breadth of pharmaceutical development expertise provides you with a single, integrated source for efficient problem-solving strategies and scientific expertise. Whether your needs are comprehensive or tightly focused on a specific project, our experienced CMC consultants will help keep your drug development program on track. Not just advice. DSI provides you with hands-on, flexible resources and expanded operational capability, to implement a compliant drug development strategy and timelines.
- 网站
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https://www.dsinpharmatics.com/
DSI - DS InPharmatics, a PLG company的外部链接
- 所属行业
- 商务咨询服务
- 规模
- 11-50 人
- 总部
- Harleysville，PA
- 类型
- 私人持股
- 创立
- 2007
- 领域
- CMC Operations、Quality by Design、CMC Project Management、Technical Authoring、IND、NDA、BLA、Drug Development、Regulatory Affairs、Quality Assurance、Breakthrough Therapy Designation、Chemistry Manufacturing and Controls、Biotech、Pharmaceuticals、Submission Authoring、Regulatory Strategy和Expedited Drug Development
地点
DSI - DS InPharmatics, a PLG company员工
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Bettina Kaplan
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Nancy Harper
Consultant at Pharmaceutical Advisors LLC and Design Space Inpharmatics
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Michael Carroll
Senior Consultant- Microbiology/Aseptic Manufacturing - Self-employed and through DSI - Design Space InPharmatics LLC (part of Product Life Group)
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Susan Fasso
President Global Pharma GxP Consulting
动态
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Looking for inspiring reads to elevate your knowledge and fuel your growth? Take a moment to recharge and expand your expertise with our resources! Subscribe to our email list for free access to blogs, podcasts, updates, resources, and more. Your learning journey starts here: https://bit.ly/4j8Npqo #SubscribeNow #KnowledgeIsPower #DSI #HealthcareInnovation
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At DSI, we focus on delivering efficiency, robust quality systems, and tailored development-stage implementation. Our mission? To exceed the expectations of regulators, sponsors, and investors while streamlining your QA processes. Discover how DSI ensures seamless quality assurance every step of the way: https://bit.ly/4kUezmm Stay tuned for more insights, and let’s make quality assurance a streamlined and successful journey together! #DSIQualityAssurance #EfficiencyInAction #QualityExcellence #RegulatorySuccess
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A well-executed supply chain is the backbone of organizational success. At DSI, our expert team offers customized solutions to streamline efficiency, cut costs, and elevate performance. Let us help you achieve operational excellence this year! Explore how our innovative supply chain services can drive impactful results: https://bit.ly/41UsIHC #DSI2025 #SupplyChainSolutions #EfficiencyRedefined #PharmaInnovation #BiotechSuccess
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Step into the future with confidence and innovation—stay ahead with DSI! Subscribe to our email list for exclusive access to expert insights, actionable strategies, and the latest trends shaping the healthcare and pharma industries. Don’t wait—make this your most informed and successful year yet: https://bit.ly/4kTZtgN #DSIConsulting #Innovation #HealthcareExcellence #RegulatoryLeadership #PharmaTrends
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Perfecting your veterinary drug’s formulation is essential for efficacy and compliance. At DSI, we specialize in tailored formulation development, ensuring your products meet the highest standards at every stage. Let’s work together to create better medicines for animals. https://lnkd.in/eMqYaEjJ #FormulationDevelopment #AnimalHealth #VeterinarySolutions #DSISupport #PharmaExcellence #VeterinaryMedicine #InnovationInAnimalCare
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QP Certification vs. QP Declaration: What’s the Difference? QP Certification and QP Declaration are both vital for EU/UK pharmaceutical compliance, yet they serve distinct roles. QP Certification is required for batch release, ensuring products meet regulatory standards, while QP Declaration focuses on API compliance, verifying GMP adherence at manufacturing sites. At DSI, our expert QPs provide both certification and declaration services, ensuring seamless regulatory compliance and market access. https://bit.ly/4im09tC #PharmaCompliance #QPDeclaration #QPCertification #GMP #RegulatoryAffairs #DrugDevelopment
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At DSI, we recognize that reliable analytical methodologies are critical to product success. That’s why we offer an integrated approach to analytical development, helping you establish robust methods for your starting materials, intermediates, and finished products. With a focus on quality, control, and compliance, we deliver results that you can trust. Learn more: https://bit.ly/4iCzMzu #DSIAnalyticalExcellence #PharmaInnovation #CommitmentToQuality
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Bringing a drug to market requires rigorous testing for safety, efficacy, and quality. Chemistry, Manufacturing, and Controls (CMC) ensures a product is consistently manufactured, stable, and meets regulatory standards. Explore the critical role of CMC in drug development: https://bit.ly/4iALECa #CMC #DrugDevelopment #Pharma #Biotech #RegulatoryCompliance
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Navigating the intricate journey of an NDA submission? DSI is here to lead the way! Our expert regulatory project managers bring precision, organization, and leadership to every step of the process. From aligning cross-functional teams to managing agency communications, we ensure timelines are met, risks are mitigated, and your submission stays on track for success. Partner with us for confidence in your next NDA submission: https://bit.ly/4bDcpDE #NDASubmission #RegulatoryAffairs #PharmaExcellence #ProjectManagement #DrugDevelopment #LifeSciences #BiotechSuccess #DSI #RegulatoryConsulting
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