ABOUT CAPSTONE
DEVELOPMENT SERVICES
Since its founding in 2013, Capstone has been one of the first shared services organizations to utilize its business model to partner with global pharmaceutical and medical device companies to bring innovative healthcare products to market. Capstone leads development, manages regulatory services, and achieves timely approval of healthcare products. With a highly experienced research and development team, they shepherd each product from concept to approval, helping their partners achieve rapid, scalable growth.
Capstone advances the goals of its corporate partners by bringing new healthcare products to market quickly and efficiently, allowing its clients to expand their product development portfolio without increasing their operating expenses. This approach augments R&D efforts already in place by their clients by providing the necessary capital and human resources to usher the designated projects to completion.
To date, Capstone’s unique approach has resulted in regulatory approvals on more than 20 products in the United States, European Union, and Canada.
OUR EXPERIENCE INCLUDES
CORE CAPABILITIES INCLUDE
Technical Project Management
Team of scientists with broad experience leading all phases of drug and medical device development, including:
- Formulation and process development of innovative and complex generics following ANDA and 505(b)(2) NDA approval pathways
- Analytical research and development supporting the characterization of small molecules, peptides and recombinant biologics
- Combination drug product development, including special expertise in complex delivery systems (e.g. premix IV bags, autoinjectors, implants, pre-filled syringes, and transdermal systems)
Regulatory Affairs
A skilled team of professionals to provide comprehensive regulatory services, including:
- Provide strategic regulatory input to the drug development process to ensure later stage success
- Extensive experience preparing and submitting high-quality regulatory applications for ANDA and 505(b)(2) NDA products
- Track record of timely FDA, EMA & Health Canada approvals of multiple complex drug and drug-device combination products
- Life-cycle management of commercial products, including: product labeling, advertising & promotional materials review, regulatory compliance report generation, and strategic product change assessments
Scientific Affairs
A broadly experienced cross-functional team that collaborates with product development, clinical, regulatory affairs, and key partners to execute innovative model-informed strategies for drug development (MIDD). The Scientific Affairs team implements advanced quantitative methods and analyses to integrate data from in vitro biopharmaceutics models, in vivo pre-clinical models, and in vivo clinical studies to accelerate development and regulatory approval of complex products.
Clinical Operations
An experienced team in all phases of clinical development, with focused work on complex bioavailability/bioequivalence studies and medical device studies. Clinical Operations also includes an extensive network of partners and consultants that serve as subject matter experts. Together, our internal and external experts have engineered novel approaches for clinical drug and medical device development and have completed successful studies supporting product approvals in the U.S., EU and Canada.
Medical Device Development
Broad technical expertise and resources to support our partners’ projects, including:
- Senior leadership with success across a broad spectrum of medical devices
- A track record of innovation to expedite timelines for design and development of small-scale to multi-year projects
- Clinical Operations team to design and execute regulatory studies to support 510k and PMA applications
Medical Device Development
Broad technical expertise and resources to support our partners’ projects, including:
- Senior leadership with success across a broad spectrum of medical devices
- A track record of innovation to expedite timelines for design and development of small-scale to multi-year projects
- Clinical Operations team to design and execute regulatory studies to support 510k and PMA applications
Extended Capabilities
Combination Device Development
Biosimilar/Complex API Characterization
Quality Assurance
Commercial Operations
Supply Chain & Logistics
Model Informed Drug Development