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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
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