Capstone
Capstone Development Services is an innovative shared services development company focused on complex pharmaceuticals and medical devices. Founded by Water Street Healthcare Partners, it leads development, manages regulatory services, and achieves timely approval of healthcare products through partnerships with global pharmaceutical and medical companies. The company has developed and gained regulatory approvals for more than 20 products across the US, EU, and Canada, and continues to bring new healthcare products to market.
Industries
Nr. of Employees
medium (51-250)
Capstone
Rosamond, Illinois, United States, North America
Services
Shared-services model providing cross-functional leadership and resourcing to advance partner development programs from concept through regulatory approval.
Strategic regulatory input and preparation of regulatory applications for abbreviated and hybrid regulatory pathways and ongoing post-approval regulatory management.
Application of advanced quantitative methods to integrate preclinical and clinical data streams to inform development strategy and regulatory interactions.
Design and management of clinical programs including bioavailability/bioequivalence and device clinical studies, leveraging internal and external subject-matter experts.
Technical resources and leadership for device design, development planning, and clinical/regulatory study support to enable 510(k) and PMA pathways.
Analytical method development and characterization services for small molecules, peptides, recombinant biologics, and complex APIs to support development and regulatory filings.
Shared-services model providing cross-functional leadership and resourcing to advance partner development programs from concept through regulatory approval.
Strategic regulatory input and preparation of regulatory applications for abbreviated and hybrid regulatory pathways and ongoing post-approval regulatory management.
Application of advanced quantitative methods to integrate preclinical and clinical data streams to inform development strategy and regulatory interactions.
Design and management of clinical programs including bioavailability/bioequivalence and device clinical studies, leveraging internal and external subject-matter experts.
Technical resources and leadership for device design, development planning, and clinical/regulatory study support to enable 510(k) and PMA pathways.
Analytical method development and characterization services for small molecules, peptides, recombinant biologics, and complex APIs to support development and regulatory filings.
Expertise Areas
- Clinical trial management
- Bioavailability and bioequivalence studies
- Formulation and process development for complex generics
- Combination drug–device development
Key Technologies
- Model-informed drug development (MIDD)
- In vitro biopharmaceutics modeling
- In vivo preclinical models
- Bioavailability / bioequivalence study design
News & Updates
More History
Details about the company's history and milestones.
About Capstone Development Services
Overview of the company's mission, history, and achievements.
Meet the Team - Ellen Hoffing
Profile of Ellen Hoffing, Chief Business Officer & Chief Financial Officer.
Our Heritage
Historical milestones and founding timeline of Capstone Development Services.
Meet the Team - Stacie Switzer
Profile of Stacie Switzer, Chief Legal Officer.
About Us
Information about the company's founding, mission, and core capabilities.
More History
Details about the company's history and milestones.
About Capstone Development Services
Overview of the company's mission, history, and achievements.
Meet the Team - Ellen Hoffing
Profile of Ellen Hoffing, Chief Business Officer & Chief Financial Officer.
Our Heritage
Historical milestones and founding timeline of Capstone Development Services.
Meet the Team - Stacie Switzer
Profile of Stacie Switzer, Chief Legal Officer.
About Us
Information about the company's founding, mission, and core capabilities.