| 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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