Concept2Clinic Incorporated is an Executive R&D Management Company built on the “united we stand, divided we fail” concept. In today’s economy and with the complexity of drug development and global regulatory requirements, it is impossible for any one entity to do it all themselves. At C2C we realize and embrace this and consequently work with our clients, regulators, and a network of consultants and preferred service providers to make clinical investigation of your intellectual property a reality. What we bring to the table is a fully integrated drug development team with an aggregate 198 years of pharmaceutical development experience. When C2C signs a contract, we take full accountability for your drug development program and will act as your entire R&D division, removing the need for you to develop this infrastructure on a full time basis. C2C will provide your company with a “part-time” R&D Executive who will be an integral part of your management team to help define your development strategy, ensure compliance with global regulatory requirements and make certain the development is technically sound with execution on time and on budget. Additionally we will provide your company with the project management and flexible capacity not only to advise you but to execute preclinical to clinical proof of concept, technology and site transfers, and commercialization. We will fill the gaps with experience across the development chain meeting Quality and CMC objectives.
As an executive R&D management company, let us help you:
- Perform due diligence and assess opportunities
- Advise on development and regulatory strategies
- Manage all aspects or any individual element of the execution of your development or technology transfer plan
- Integrate your development programs across all service providers to ensure a comprehensive, cohesive and compliant data package
- Provide experts for interactions with regulatory authorities
- Provide additional capacity or capability to your organization to meet corporate objectives
- Provide expertise to resolve technical issues and ensure quality and compliance for optimization
Concept 2 Clinic Inc (C2C) is an executive R&D management company specialized in the pharmaceutical and biotechnology sectors targeting emerging companies and academic research projects bridging the gap between bench and clinic recognizing companies that lack the capacity and, or capability to develop their own infrastructure, small to midsize organizations alike.
With our extensive experience and ability to be flexible, creative and economical in today’s challenging environment, C2C is truly an enabler and well suited to support client’s efforts to advance discovery and innovation and be technically strong. Success is in the strength of the strategy and execution.
||Vendor Selection, Audit, Management
|Government Grant Application
||Timeline and Budget Accountability
||Formulation/Process Development/ Technology Transfer
||Regulatory / Quality
||Regulatory Body Interactions
||Document Preparation and Filing
||Site Selection, Audit, Management
|Pre-clinical to Commercialization