Design Space InPharmatics LLC

BioTech/Drugs - Harleysville, PA, US

Design Space InPharmatics LLC Employees
Colman Byrne

Head of Analytical Services

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Rick Offerman

Senior Project Management Consultant

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Jim Klancke

Sr. Project Management …

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Michael Carroll

Senior Consultant- Microbiologist

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Paul Long

Project Management Consultant

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David Adams

Senior Drug Substance Consultant

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Design Space InPharmatics LLC Details

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.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.

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Employees: 50 - 99
HQ: 855-805-8402
Location: Harleysville, PA, US
Revenue: 5 - 10 Million
CMC Operations CMC Regulatory 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 Expedited Drug Development BioTech/Drugs Commercial Physical Research Biotechnology
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