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• Study feasibility and site identification • Investigator selection and site validations • Ethics Committee and Medsafe (SCOTT) applications • Investigator site initiations • Site management including monitoring throughout New Zealand and Australia • Broad therapeutic experience including Cardiovascular, Oncology, Urology, Nephrology, Endocrinology, Psychiatry, Respiratory, Neurology • Expertise in monitoring Phase I to Phase IV clinical trials • Compliance to local and international standards and guidelines, e.g. ICH-GCP Regulatory Affairs Service: • New Medicine Applications • Changed Medicine Notifications • Reclassification Applications • Labeling and Data Sheet requirements • Regulatory strategy advice and documentation requirements for applications in N.Z. Additional Services include: • Quality Assurance/Audits • Development and/or improvement of in-house standard operating procedures • Promotional and advertising material compliance Pharmaceutical Solutions provides a customised service depending on the needs of the client. The company has a network of experienced and specialised personnel who are available to work with the client to provide solutions for a variety of clinical research and regulatory affairs needs.
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