Oversight of CROs
Outsourcing is a major business model supporting drug development for small and large biotech firms. The first priority is to identify and quality CROs capable of meeting tight timelines and while maintaining superior procedures. The quality of the facility contributes to the quality of the final product. To assure continued excellence in all aspects related to development of a biologic requires attention to detail, strong scientific skills, and exceptional communication. Our customer-focused model strives to deliver outstanding service in the oversight of outsourcing partners.
qualification of cros
Prior experience provides a solid foundation for understanding the complexities of managing timelines and deliverables at a CRO. Driving relationships with multiple CROs as a pharmaceutical company customer provides additional skills for guiding success with outsourcing. Our services include preselecting CROs that match requirements as well as auditing CROs to assure compliance with regulatory expectations.
gmp compliance for release / stability testing
We will conduct thorough analysis of compliance at each facility involved in testing samples for release of manufactured drug substance/drug product. The same auditing principles will be applied for facilities performing stability testing.
qualification of cell bank facilities
Standard operating procedures, quality practices, training, storage, and monitoring are crucial areas audited when selecting cell bank facilities. We will collect information on the ability of a facility to securely store cell banks. Included in this assessment is an analysis of all auxiliary procedures pertinent to security of the cell bank.
glp compliance for preclinical / clinical sample testing
We will audit the facilities involved in the life cycle of samples from collection through testing to disposal. In addition, we will guide the processes of data collection and delivery for the analysis of pharmacokinetic parameters.