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 Workforce - 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
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