Compliance Consultants
CAREERS   |
Our Compliance Group specializes in quality procedures, programs and management consulting in US and European regulated areas to include:  Audits, Remediation, Quality Systems, Validation and Qualification of Process, Cleaning, Environment, and Computerized Systems.

Our team developed and implemented many plant wide systems to assure compliance.  Our extensive database includes formats and templates to get the project off and running and maximize the efficiency in development.  Our expert staff is ready to implement and assist you in many different areas.
Services
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Program & Project Management
  • Program Managers
  • Project Managers
  • Project Tracking & Controls Specialist.

Compliance Assessments, Audits & Remediation
  • Assessments
  • Mock Pre-Approval Inspections
  • Vendor/Supplier Audits
  • Warning Letters
  • Remediation

Quality Systems
  • Compliance Programs
  • Policies & Procedures
  • CSV/SDLC

Engineering & Commissioning
  • Factory Acceptance Testing
  • Design Review & Qualification
  • Commissioning
  • Documentation Requirements
  • Professional Engineers

Process Validation
Preparing for Validation
  • Validation Master Plan
  • Qualification Approach
  • Validation Procedures

Equipment Validation
  • Manufacturing Equipment
  • Lab Equipment
  • Utilities

Cleaning Validation
  • Analytical Methods
  • Sampling
  • CV Protocols

Computer System Validation
  • IT & Manufacturing Systems
  • Software & SAP
  • Computer Systems Validation
  • SDLC

Laboratory
  • Methods Development
  • Procedures
  • Lab Support
  • Sampling Plans
  • Equipment Validation
  • Analytical Methods Validation
  • Lab Relocation