Commercialization

Manufacturing/Packaging Process and Equipment:

Equipment assessment and trouble-shooting.

Preventive/Annual maintenance, repairs and rebuilds.

Mechanical aptitude assessment.

Design and/or delivery of Mechanical and Electrical training programs.

Technical:

Total technology management.

Equipment qualification.

Manufacturing troubleshooting – product and process.

Technology transfer.

Technical writing – plans, protocols and reports.

SOP – preparation and modification.

Documentation auditing.

Validation Consultation:

Equipment (IQ, OQ, PQ).

Facility / Utility.

Computer system and software.

Commissioning, start-up and qualification for production facilities,
including utilities, equipment and control systems.

Protocol Development / Execution.

SOP – preparation and modification.

21 CFR Part 11, electronic records/electronic signature.

Analytical:

Method development and transfer.

Analytical testing – development through commercialization.

Laboratory equipment IQ, OQ, PQ.

Product Development:

Excipient/Ingredient compatibility and selection.

Product and process development and validation.

Manufacturing scale-up support.

Technology transfer.
Training and Technical Aptitude:

GMP.

GLP.

GCP.

Line-level leadership technical training.

Mechanical and Electrical aptitude assessment.

Design and/or delivery of Mechanical and Electrical training
programs.

Health and Safety training program development and/or delivery.