Accellient Partners
About Us
Our Team
Products and Services
Our Model
Contact Us

Proven expertise across the drug development continuum

Accellient Partners LLC is a fully integrated and dedicated team of drug development experts that design, implement and manage the strategic, tactical, and regulatory-driven product development needs for the biotechnology and pharmaceutical industry. To meet the diverse needs of our clients we provide the following services:

Our expertise includes:
Integrated Drug Development
Chemistry, Manufacturing, and Controls
Nonclinical Development
Start-up Support


Fully integrated program service costs (including vendor selection, vendor cost and vendor management, from manufacturing, nonclinical and IND submission through Phase 1) average from $1.5M to $4.0M for most small molecule projects and are delivered in 9 to 18 months. Accellient can also manage protein therapeutic programs. For the lowest possible cost and shortest timeline, Accellient will guide your company to its next financeable milestone or exit. Our validated approach helps our clients establish parameters of value and measure those values against program goals.


Development starts with the synthesis of the test article, making active pharmaceutical ingredient (API) production a critical element to any drug development program. Our comprehensive drug development expertise encompasses development and manufacturing services to support all phases of CMC for a product from discovery through commercialization for small molecules, antibodies, therapeutic proteins, oligos and cell based therapies.
Our management services include:


Accellient recognizes the criticality of making the correct nonclinical decisions the first time; our staff has been doing this well for over 25 years. Avoiding errors at this early stage will minimize expensive delays in development and maximize ROI. We will develop and manage an approvable program in the most efficient and productive manner to enhance the opportunity for regulatory and clinical success.
Accellient’s nonclinical support services cover all areas of preclinical research and development and include:


Accellient’s Regulatory Affairs team provides strategic guidance and management based on our clients’ program goals while also keeping the potential concerns of the regulatory authorities top of mind to minimize risks to program approval. Our team works with all major divisions of the FDA and has experience managing:

We also have significant experience in eCTD submissions through FDA approved portals with our alliance partners and are currently filing eIND’s on a quarterly basis.


Accellient’s clinical development experts have substantial hands-on experience in the development of small and large molecule therapies and will build a clinical plan that will minimize risks and improve approval prospects to maximize your program’s value.  Our core competency is on clinical programs from Phase I through Phase II proof-of-concept.
Our clinical services include:


Accellient Partners can also assist you with your fund-raising process and provide start-up financial management and accounting support for your company or drug development programs as needed.




©2015 Accellient Partners® LLC