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