Regulatory Strategy and Gap Analysis FDA Meeting Strategy FDA Submissions Regulatory Due Diligence Chemistry, Manufacturing and Controls (CMC) Pre-Approval Audits Non-Clinical Drug Development
GCP)Audits, Clinical Staffing- CRA/CRC/Project Manager Clinical Data Management Clinical Operations-Biostatistics and Programming Clinical Pharmacovigilance (PV) Auditing Services Clinical Program and Project Management Vendor Management and Oversight Vendor audits Clinical Pharmacovigilance (PV) Auditing Services
External Supply Quality and Technical oversight of (CMO)Contract Manufacturing Organizations Quality Management Systems (QMS): Deviations, OOE/OOS, CAPA, APRs, Change Controls, SOPs-GOPs Commissioning, Qualification, and Validation-Process Validation, Cleaning and Sterilization Validation, Equipment and Facility Engineering
Evaluation of API and Finished Dosage Form transportation from manufacturer to end users Cold Chain Compliance Serialization/UDI Track and Trace-Interoperability Falsified Medicines Directive Compliance Supply Chain Process Mapping Selection, evaluation, auditing, and validation of Transportation Companies and Distribution Centers
Pharmavise is a (CCO) Contract Compliance Organization. We are a turnkey regulatory compliance consulting firm with Global Capabilities deliverable throughout the Product Lifecycle.
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