Overview of our Services

Quality Systems

Quality Systems Development and Implementation.
Design Change Control Systems
Product and Process Control
Product Development
Process Automation and Methods Improvement
Risk Management
Sigma Six Analysis

Audits

GMP and QS Regulation Compliance Audits (Good Manufacturing Practice and Quality System)
GLP and GCP audits (Good Laboratory Practice and Good Clinical Practice)
Design Control audits
Clinical study audits
Simulated audits

Compliance

Regulatory Compliance (QSR, ISO, EU) and Compliance Audits (Quality Systems Regulation QSR, International Standards Organization ISO, EU European Union)
QA/QC Development (Quality Assurance/Quality Control QA/QC)
Validation and Generation/Development/Review of SOPs (Standard Operating Procedure SOPs)
On Market Product Maintenance and Monitoring
CAPA (Corrective And Preventative Action)
Gap Assessments

FDA Submissions and Responses

FDA Submissions and Liaison
FDA Warning Letter Response and Action Strategies

Employee/Staff Training

Training programs for employees in QS Regulations (Quality Systems – QS Regulations)
Training in GMPs, GCPs, and GLPs (Good Manufacturing Practice – GMPs, Good Clinical Practice – GCP and Good Laboratory Practice – GLP)

Technical Writing

Generation and development of SOPs (Standard Operating Procedure)
Manuscript preparation and submission assistance
Grant application preparation