Regulatory compliance and training services at a worldwide level in:

• FDA laws and regulations
• Data integrity audits
• Technolgy transfer and technical support
• Benchmarking studies and harmonization practices
• Risk management policies, procedures and implementation as per ISO
• Regulatory inspections support
• cGMP training to manufacturing, laboratories and engineering
• GLP assessment to toxicology and clinical studies
• Auditing support and services on all areas enforced by regulatory agencies (FDA,
• DEA, EMEA, MCA, ANVISA)

NEW PRODUCT INTRODUCTION
Specialized services in the following areas:

• New product introduction
• Product registration
• Process control and QA/QC metrics
• Analytical method transfers
• Project management
• PMA support for Pre-Approval Inspections
• NDA support for Pre-Approval Inspections
• BLA support for Pre-Approval Inspections
• Validation and qualification services
• Equipment and facility commissioning

VALIDATION SERVICES
Specialized services in the following areas:

• Validation master plans
• 21CFR Part 11 services
• CSV applications: URS, FRS, FATs, SATs
• Gap analysis and compliance remediation plan
• Vendor qualifications
• IQ, OQ and PQ qualification documents as per FDA and international requirements
• Validation protocols and reports as per FDA and international requirements
• Quality manuals as per ISO
• Risk management guidelines as per ISO
• New facility acquisitions due diligence support

QA/QC AND COMPLIANCE
Specialized services in the following areas:

• Change control management and procedures
• Customer complaint management and procedures
• CSV life cycle development and procedures
• Inventory control
• Investigations and Corrective and Preventive Action Program (CAPA)
• Supplier evaluation and certification program
• General QA/QC policies, procedures and guidelines
• Laboratory cGMP assessment
• Packaging and labeling assessment
• Six Sigma and Process Excellence support for cost reduction

QUALITY AND COMPLIANCE AUDITS
Specialized services in:

Drug diversion, site security and system integrity
Technical support on special investigations
Product recalls
Special audits to service providers of:

• Gamma radiation and ETO sterilization
• Raw material suppliers
• Medical device reporting (MDR)
• Adverse drug events (ADE)
• Clinical investigations

3rd party auditing and certification upon FDA regulatory action