Services

Auditing Services

Quality Management Systems

Quality Management Systems

GMP Compliance Audits
GLP Compliance Audits
Due Diligence
Deficiency Resolution
Gap Analysis Audits
Mock Pre-Approval Inspection
Supplier Audits

Quality Management Systems

Quality Management Systems

Quality Management Systems

Quality Manual
Change Control
Deviations
Investigations
CAPA
Internal Audits

Training

Quality Management Systems

Supply Chain

Good Manufacturing Practices
Good Laboratory Practices
Audit Conduct
Supplier Qualification Programs
All courses can be instructor lead or webinar

Supply Chain

Manufacturing

Supply Chain

Development of Quality Agreements
Design of Supplier Quality Management Programs
Audits of supply chain including API, excipients, container/closure provider, CMOs, contract testing facilities, GLP providers

Manufacturing

Manufacturing

Manufacturing

Process Validation
Cleaning Validation
Equipment Qualification and Validation
Manufacturing Batch Records
Packaging Batch Records
Technology Transfer

Analytical

Manufacturing

Manufacturing

Analytical Support for Cleaning Validation
Analytical Equipment Qualification and Validation
Laboratory Controls
Analytical Method Validation
Anaytical Method Transfer
Raw Material Testing and Controls
Stability

Additional Services

Technical Writing Assistance

Technical Writing Assistance

Technical Writing Assistance

Support in writing of qualification/validation protocols/reports
Support in writing of manufacturing and testing documentation
Support in submission writing

Project Management

Technical Writing Assistance

Technical Writing Assistance

Quality Support

Technical Writing Assistance

Quality Support

Provide additional support in the review of batch records
Provide additional support in the review of test reports and associated data
Provide support in the review of submission files and source data