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SSPCC is equally confident working with major pharmas as with start-up biotech and academic ventures.
We provide the following services to our clients: - Recommendation of package of preclinical studies needed for new drug applications through to Phase IV regulatory requests
- Development of Safety Assessment Package, as independent 3rd party consultant to provide unbiased selection of appropriate studies, design, and cost analysis
- Liaison and project management of CROs, pulling together all the individual studies to centralize, oversee, and streamline the process
- Coordination and management of documentation for New Drug Applications (NDA) and Investigational New Drugs (IND)
- Liaison for academic institutions and pharmaceutical companies
- Independent 3rd party review of Good Laboratory Practices (GLP)
- Lab planning and budgeting
- Coaching of new recruits from academia to better transition them to the differing demands of the pharmaceutical industry and regulatory requirements
- Streamlined processes and procedures
- Staffing help during cyclical periods of overload
SSPCC is poised to help you secure corporate funding, venture and private equity in addition to the following services: Facilitating corporate partnering between companies Identifying and in-licensing/out-licensing technologies and products Developing and implementing business plans Providing interim business development management for early stage companies Assessing technologies, intellectual property, products and providing valuations Access to capital Developing and implementing product development plans to support licensing approval
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