SERVICES
Services
Our Specialities
GLP-Regulatory Strategy
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-Clinical
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
GMP-Manufacturing
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
GDP-Distribution
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
Industries Served
Pharmaceutical
Medical Device
Vaccines/Biologics
Biotech
Pharmavise is a (CCO) Contract Compliance Organization. We are a turnkey regulatory compliance consulting firm with Global Capabilities deliverable throughout the Product Lifecycle.
Contact Details
- 3301 N University Dr Suite 100, Coral Springs, FL 33065-4149, USA
- info@pharmavise.com
- 8 AM - 5 PM , Monday - Saturday
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