Our consultants possess extensive knowledge
of the pharmaceutical industry and are well versed in all global
regulatory requirements. Our team has been involved in numerous
regulatory compliance initiatives including:
• 21 CFR Part 11 assessment and remediation
• Computer System Validation
• Risk Management
•
Process Validation
•
Compliance Readiness Assessment
•
Training of Quality Personnel
•
Electronic Regulatory Submissions Process Implementation
•
Vendor Qualification
•
Qualification of Contract Organizations
•
Qualification of Service Providers
•
Authoring of Quality Policies and Procedures
•
Implementation of Quality Programs
We provide our client practical solutions. Our standardized approach
to performing assessment and implementation of remediation has
proven to be successful in all of our engagements. We ensure proper
assessment by identifying and interviewing appropriate personnel
within our sponsors and their vendors. Successful
implementation
of remediation is assured through our standard multi-phase project
management approach which includes project initiation, data
collection and analysis, implementation, training and closure.
Our auditors have performed audits of
diverse scope
on behalf of life science companies worldwide. Their vast experience
and standardized approach allows us to assist companies with the
development or improvement of quality programs, quality control,
quality management processes, procedures and controls.
