COMPLIANCE AND REGULATORY

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

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

21 CFR Part 11, electronic records/electronic signature