PharmaLogika consults with pharmaceutical, biotech, and medical device quality units to provide third party audits, pre approval inspections (PAIs), compliance remediation, and a portfolio of related quality and regulatory affairs products and services. Regulatory action guidance as well as quality systems guidance are delivered as part of our standard products and services. Through the use of highly skilled resources throughout the process, each offering is designed to enact a comprehensive quality systems approach in addressing Quality Assurance (QA) issues. The results insure a close adherence to current Good Manufacturing Practice (cGMP) standards.

Remediation services are offered in response to communications (Form 483 observations, warning letters, and consent decrees) received f