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Assist in the cGMP design of facilities for the manufacture of biological products
- Facility
design regarding HVAC control, containment, and process, personnel
and waist flow
- Equipment
qualification and cleaning
Assist
in development and monitoring manufacturing process controls
- Aseptic
process validation
- Environmental
monitoring
- Qualification
of single use systems
Assist in the preparation of regulatory submissions to the FDA
- Review
and provide feedback on meeting requests and briefing packages
regarding facility designs for all phases of biological drug
products
- Review
and provide feedback on CTD submissions regarding microbiological
control and the Facility and equipment, appendix 3.2.A.1
Perform facility cGMP audits, IND phase specific and post approval
- Quality
System
- Production
System
- Facilities
and Equipment System
- Materials
System
- Packaging
and Labeling System
- Laboratory
Control System
Provide cGMP training
- All
phases of product development including post approval
- On
site or webinar
- Tailored
to specific needs
Present at scientific and regulatory conferences
- cGMPs
all phases of biological drug development
- Microbiological
control in production of biological drug products
- Facility
design for manufacture of biological products
- Facility
designs for cell and gene therapy products
