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

Sterility Assurance

  • Develop a Corporate Sterility Assurance program
  • Training, development, and qualification for steriliziation and depyrogenation
  • Aseptic Process revision and/or Facility Design
    • Revision of production deviations, non-conformities, and other investigations
    • Resolution of FDA 483, EMA or local authority compliance deviations
    • Validation of microbial sampling systems and isolators for sterility testing 

Quality by Design (QbD)/Process Analytical Technology (PAT)

  • Advice on how QBD / PAT may be incorporated in the business system
  • Applying “Comparability Protocols” and other regulatory strategies for deployment

Pharmaceutical Microbiology

  • Environmental monitoring evaluation and development 
  • Evaluation and development of protocols and cleaning procedures
  • Evaluation and development of procedures, policies and standards for media fills
  • Laboratory Management
    • Optimization of laboratory policies, procedures, equipment, and methods
    • Sterility test analysis and evaluation of positive sterility failure tests.
  • Development of rapid methods for sterility testing
  • Microbiological Data Deviations (MDD) and Analysis of Out-of-Specification (OOS)
    • Program development and review of microbiological
      data deviations and out-of-specification
    • Implementation of corrective action plans for reducing and/or eliminating MDD or OOS

Alternative Microbiological Methods

  • Methodology review and education
  • Management approval, project management, and implementation support
  • Market analysis and advice on needs and product specification development for RMM

Production Support

  • Process optimization, risk assessment, and project management assistance
  • Comparability protocols for processes/analytical changes
  • Cleaning and sanitization of cleanrooms including process analysis, practices, procedures, and rationales/rotations

Quality Assurance Support

  • Development of Quality Management Systems (QMS)
  • Evaluation of systems based inspection compliance programs
  • Support implementation of quality problem solving tools
  • Assist in inspection resolution, reduction, and root cause analysis

Risk Assessment

  • Performed using Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HACCP), and other methods
  • Evaluation of laboratories, production, and quality operations
  • Development of programs and procedures
  • Review of data trends and recommendation of alert and action levels

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?