The experts you need, when you need them

Crisis Handling

  • Consent decree
  • Disaster recovery
  • Contamination outbreak
  • FDA 483 and EMA response

Advising, Training & Performing

  • PAT, QRM and QbD
  • Risk analysis
  • Analytical methods
  • Process understanding

Validation & Calibration

  • Process
  • Computer Systems
  • Equipment
  • Cleanroom

We have the experts to support you at every step of your process, whether it be non-compliance issues, setting up a new process, or training employees. Our team has the background and education you need. Their ongoing dialogue with different regulatory agencies provide a continuous update of new regulatory requirements.

Advisory services

Training

Our experts provide onsite training including:

  • Fundamentals of microbiology
  • Personnel hygiene GMP
  • Contamination control
  • Cleanroom protocols
  • Cleaning and sanitization GMP 
  • Alternative microbiological methods implementation
  • Risk assessment management 
  • Media-fill protocols
  • FDA and EU guideline interpretation
  • Regulatory updates
  • Training courses for professional development tailored to your needs

EXPERT REVIEW OF OPERATIng PROCEDURES AND PROCESSES 

We offer training of operators and analysis of process operations at your facility for:

  • Operators in production areas
  • Supervision of pharmaceutical processes
  • Quality Assurance and Quality Control Laboratories
  • Engineering and Maintenance personnel
  • We can also provide evaluation tests for competency and training certificates

How can we help?