Need support to keep your projects on track? Our dedicated Project Managers are here to ensure timelines stay on target and scope remains aligned with your strategic goals. Reach out today to see how we can drive your project’s success: Learn More https://bit.ly/487GI3A #ProjectManagement #PharmaExperts #ProgramManagement #Pharmaceuticals #DrugDevelopment #Biotech #ClinicalResearch #LifeSciences #PharmaIndustry #ProjectSuccess
DSI - DS InPharmatics, a PLG company
Business Consulting and Services
Harleysville, PA 4,492 followers
a ProductLife Company offering end-to-end CMC, QA, and Regulatory Services. We solve your drug development obstacles.
About us
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.
- Website
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http://www.dsinpharmatics.com/
External link for DSI - DS InPharmatics, a PLG company
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Harleysville, PA
- Type
- Privately Held
- Founded
- 2007
- Specialties
- 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, and Expedited Drug Development
Locations
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Primary
PO box 532
Harleysville, PA 19438, US
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Boston, Massachusetts 02114, US
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San Francisco , CA 94015, US
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San Diego , CA 91945, US
Employees at DSI - DS InPharmatics, a PLG company
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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
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Susan Fasso
President Global Pharma GxP Consulting
Updates
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In our latest thought leadership piece, Colman Byrne, Head of Analytical Services at DSI, shares his insights from over 40 years of industry experience. He discusses the critical role that analytical services play in ensuring pharmaceutical products' safety, effectiveness, and quality. Colman also highlights DSI’s hands-on approach with contract labs, guiding clients through troubleshooting, regulatory filings, and optimizing development processes. Don't miss out on this valuable interview to see how DSI can support your development programs. Read the full piece here: https://bit.ly/3NkYt5L #Pharma #Biotech #AnalyticalServices #PharmaceuticalDevelopment #DrugDevelopment #RegulatoryAffairs #QualityManagement #ThoughtLeadership
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Unlike traditional compliance solutions that demand extensive time and resources, DSI’s CMC HealthChek™ leverages best practices and innovative approaches to streamline the process and minimize costs. Ready to accelerate your compliance strategy? Contact us to learn more: https://bit.ly/3ZRnEV4 #ComplianceSolutions #CMCHealthChek #PharmaInnovation #CostEfficiency #RegulatoryAffairs #DrugDevelopment #PharmaExperts #Pharmaceuticals #Biotech #LifeSciences
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Ensuring early product and process characterization is crucial for manufacturing readiness, especially when it comes to breakthrough therapies. DSI provides comprehensive support to streamline these critical activities and accelerate your path to success. Learn more about our expedited drug development solutions: Find Out How https://bit.ly/3Yfybs0 #DrugDevelopment #Pharmaceuticals #ProcessCharacterization #Biotech #ManufacturingReadiness #PharmaExperts #ClinicalResearch #RegulatoryAffairs #LifeSciences #PharmaIndustry
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Stay ahead of industry trends and gain exclusive insights! Join our email list to be the first to receive company announcements, new blog releases, expert tips, and more. Don’t miss out—subscribe today: Get Access Here https://bit.ly/3ZWuo3U #PharmaNews #IndustryInsights #Pharmaceuticals #DrugDevelopment #Biotech #PharmaCommunity #PharmaExperts #LifeSciences #ClinicalResearch #RegulatoryAffairs
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Our panel of drug substance experts share critical insights on the declining number of API manufacturing professionals in the U.S.—a trend that could impact the future of the industry. Hear what they have to say: https://bit.ly/3ZQzn6n #Pharmaceuticals #DrugSubstance #APIManufacturing #PharmaIndustry #PharmaExperts #DrugDevelopment #Biotech #LifeSciences #PharmaTrends
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Keeping your clinical trials on track and prepared for launch requires seamless supply chain management. DSI ensures your clinical trial materials are maintained to support smooth, uninterrupted studies. Learn more about how we optimize your supply chain for success: Read More https://bit.ly/3TWqTql #SupplyChainManagement #ClinicalTrials #Pharmaceuticals #DrugDevelopment #ClinicalResearch #PharmaExperts #Biotech #PharmaIndustry #ClinicalSupply #LifeSciences
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Bringing a product to market—whether it’s your first or your next—requires strategic foresight and meticulous planning. Each milestone and regulatory nuance can be a turning point for your development strategy. Our expert regulatory affairs consultants provide the insight needed to navigate these complexities and keep your project on track. Discover how we can support your success: Learn More https://bit.ly/3BpUbYe #RegulatoryAffairs #PharmaceuticalConsulting #DrugDevelopment #RegulatoryStrategy #PharmaExperts #Biotech #PharmaIndustry #ClinicalResearch #GMP #LifeSciences
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Introducing DSI's CMC HealthChek™ – your solution for developing and managing compliance strategies for upcoming project milestones. Our CMC HealthChek™ offers a thorough gap analysis and risk assessment, delivered in an eCTD format. This approach highlights potential obstacles and provides actionable insights to navigate your project's path to the next authoring milestone. Discover how our comprehensive analysis can help you stay ahead: #DSI #CMCHealthChek #GapAnalysis #RiskAssessment #eCTD #Pharma #Biotech #LifeSciences #ProjectManagement #Compliance #DevelopmentStrategy #RegulatoryAffairs
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At DSI, our team of seasoned professionals is dedicated to transforming your program from bench scale to commercial success. Learn how our expert drug product services can optimize your product at every stage of development: https://bit.ly/4f2ffCH #DSI #DrugProductServices #Pharma #Biotech #LifeSciences #Commercialization #ProductOptimization #BenchToCommercial #DrugDevelopment