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Regulatory Affairs and Regulatory/Quality Compliance Compliance Evaluation and Support (Drugs, Devices, Biologics, In-Vitro Diagnostics, Vaccines) Establishing and improving GxP systems and procedures Assessments for New or Modified Facilities Assessments in Preparation for an FDA, EU or other regulatory inspection Assessments for specific quality and/or manufacturing systems, e.g., change control, documentation, investigations, Part 11, out-of-specification, laboratory compliance, external contract laboratories, efficiency improvements, sterilization, aseptic processing, active pharmaceutical manufacturers (APIs), supplier audits, and so forth. Training in performance of assessments, both from a technical and compliance perspective Training in specific regulatory and/or industry guidance documents Assist in responses to FD483’s, and deficiencies from other regulatory agencies Assist with regulatory letters and regulatory interface Interface with regulators, e.g., ask blinded questions of regulators Returning facilities to compliant operations following regulatory action
Regulatory Affairs Preparation of NDAs, ANDAs, PMAs, and 510(k)s Development of Chemistry, Manufacturing and Controls (CMC) sections of regulatory submissions Act as Registered Agent for Foreign Manufacturer’s of Products or APIs Preparation of Sterile Process Validation Packages (aseptic and terminal sterilization) Pre-submission review of drug and device submissions, sterile process validation packages, and documentation Paper and Electronic Submissions for FDA Comparability Protocol preparation for a variety of purposes, e.g. new or remodeled manufacturing lines changes to manufacturing sites changes to contract manufacturing sites changes in testing laboratories new or modified equipment new or remodeled aseptic areas alternative suppliers for components, active pharmaceutical ingredients, new manufacturing locations implementation of rapid microbiological methods implementation of process analytical technologies
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