Bio-equivalence Study design, protocol preparation, and review.
Clinical Services
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Identification of CRO.
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Triggering of the EU/PICs GMP inspection.
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Commercial negotiation with CRO and contractual arrangement with CRO.
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Review of BA/BE report and preparation of Module 2.4/2.7/4 and 5.
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Medical writing like Non-clinical overview, clinical overview.
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Risk assessment for BA/BE failures.
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Toxicological assessments.
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In vitro and In vivo assays of PK parameters.
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In vivo screening for various indications.
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CRO Audit.