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
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) Continuous Compliance Organization. We are a turnkey regulatory compliance consulting firm with Global Capabilities deliverable throughout the Product Lifecycle.
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