We help create the essential documents for your study.

ISF Binders – Pharmacy Binders – Regulatory Binders
Mini Protocols – Patient ID cards – Study Manuals
Leaflets & Brochures – Patient Diaries

We also have global regulatory submission expertise including coordination of wet ink signatures.

ARE YOU DEVELOPING PRODUCTS WITH THE INTENTION OF MARKETING, LICENSING, OR DIVESTING?
DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.

Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.

Consultant with 30+ years of experience in biopharmaceutical facility design and validation; clinical and commercial manufacturing; quality systems; regulatory submissions and agency inspections.

Edgerton Data Consulting assists pharmaceutical, biotech, and medical device company sponsors with CRO selection and clinical trials oversight to ensure data management, biostatistics, and CDISC deliverables are timely, complete, and accurate.

Experienced Board Member, CEO and senior executive with proven ability to build, develop and grow international businesses. A highly strategic and results focused visionary leader for building and developing early stage, turn-around, and established companies. Repeated success in leading early stage and established companies to the next level of growth and expansion. Extensive and diverse experience that provides valuable perspectives and insights to Boards and corporate management across the company in setting vision, focus, goals, and strategies that produce the best possible results. Balancing drive and passion for growth with fiscal responsibility while generating the highest possible ROI.

A full-service international consulting and product management firm that provides CMC development, manufacturing, regulatory affairs, launch, and operational support to pharmaceutical and biotech companies.​

Global experience in drug and device clinical development/safety monitoring, business development, regulatory interactions and public-private partnerships;board-certified neurologist/epileptologist;patient advocate; clinical and industry consultant.

Chris is the Principal Consultant at Xyzagen. Xyzagen is a drug discovery and clinical pharmacology consulting and services firm. Xyzagen, provides consulting, PK modeling, and nonGLP rodent pharmacology, bioanalysis and PK in their laboratory space.

Quality Assurance and Compliance; GCP/GLP/GCLP/GMP/CSV/Part 11; Training, auditing, SOPs; drugs, devices, biologics, dietary supplements

I am a Healthcare Attorney that focuses my practice on representing healthcare providers and healthcare companies on regulatory, compliance and reimbursement matters.