cGMP & Regulatory Support
At Vista Biologicals, active pharmaceutical ingredients (APIs) are manufactured in compliance with US FDA cGMP guidelines. Manufacturing is performed in facilities which have been routinely audited.
Our regulatory support includes assistance in the preparation of documents required by the regulatory authorities. This includes generation of the CMC section for an IND filing and assistance with responses to questions by the reviewing agencies.
Other services including stability studies, generation of reference standards, analytical method validation, or process validation activities in anticipation of commercial production.
Our Quality Control capabilities include:
- Testing of cell banks, raw materials, reference materials and other materials for cGMP production
- In-process, intermediate and final product release testing (bulk drug substance, drug product)
- Analytical method implementation and validation
- Environmental monitoring of classified cGMP production areas
- Monitoring of critical product contact utilities (HPW, clean steam and compressed air) for cGMP production
- Handling of raw material and product reference samples
- Analyses of samples from process and cleaning validation studies
- Process characterization studies
- ICH-compliant cGMP stability program (intermediates, bulk drug substance, drug product and placebo)
- Cell-based bioassays